U.S. patent application number 16/639632 was filed with the patent office on 2021-05-06 for compositions and methods for cognitive, immune and digestive support in patients with autism spectrum disorder.
The applicant listed for this patent is FLAASK, LLC. Invention is credited to Ken ALIBEK, Sean FARMER, Andrew R. LEFKOWITZ, Alibek MOLDAKOZHAYEV, Albina TSKHAY.
Application Number | 20210128567 16/639632 |
Document ID | / |
Family ID | 1000005343875 |
Filed Date | 2021-05-06 |
![](/patent/app/20210128567/US20210128567A1-20210506\US20210128567A1-2021050)
United States Patent
Application |
20210128567 |
Kind Code |
A1 |
LEFKOWITZ; Andrew R. ; et
al. |
May 6, 2021 |
Compositions and Methods for Cognitive, Immune and Digestive
Support in Patients with Autism Spectrum Disorder
Abstract
The present invention provides compositions and methods for
improving the quality of life for a subject, particularly a child,
diagnosed with autism spectrum disorder (ASD). In preferred
embodiments, a supplement composition comprising natural or
naturally-derived ingredients is delivered to a subject in the form
of a chocolate bar or other candy alongside administration of an
antiviral medication. Advantageously, the composition and methods
can improve the immune health of the subject, along with other
signs and symptoms associated with ASD, infections and other
immunocompromising conditions.
Inventors: |
LEFKOWITZ; Andrew R.;
(Solon, OH) ; FARMER; Sean; (North Miami Beach,
FL) ; ALIBEK; Ken; (Solon, OH) ; TSKHAY;
Albina; (Solon, OH) ; MOLDAKOZHAYEV; Alibek;
(Solon, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
FLAASK, LLC |
University Heights |
OH |
US |
|
|
Family ID: |
1000005343875 |
Appl. No.: |
16/639632 |
Filed: |
August 29, 2018 |
PCT Filed: |
August 29, 2018 |
PCT NO: |
PCT/US2018/048567 |
371 Date: |
February 17, 2020 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62551557 |
Aug 29, 2017 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A23L 33/175 20160801;
A61K 36/63 20130101; A61K 31/198 20130101; A61K 31/522 20130101;
A61K 36/48 20130101; A23L 33/30 20160801; A23L 33/105 20160801;
A61P 25/00 20180101; A23L 29/035 20160801 |
International
Class: |
A61K 31/522 20060101
A61K031/522; A61K 36/48 20060101 A61K036/48; A61K 36/63 20060101
A61K036/63; A23L 33/105 20060101 A23L033/105; A61K 31/198 20060101
A61K031/198; A23L 33/175 20060101 A23L033/175; A23L 33/00 20060101
A23L033/00; A23L 29/00 20060101 A23L029/00; A61P 25/00 20060101
A61P025/00 |
Claims
1. A supplement composition for improving the quality of life in a
subject with autism spectrum disorder (ASD), the composition
comprising: L-lysine, Elderberry extract, olive leaf extract,
Astragalus root extract, and Bacillus coagulans GBI-30 probiotic
(BC30).
2. The composition according to claim 1, the composition consisting
essentially of: L-lysine, Elderberry extract, olive leaf extract,
Astragalus root extract, and BC30.
3. (canceled)
4. The composition of claim 1, wherein the composition is
formulated as an orally-ingestible product.
5. (canceled)
6. The composition of claim 4, wherein the composition is a
chocolate bar, a gummy candy or a jelly candy.
7. The composition of claim 1, wherein each of L-lysine, Elderberry
extract, olive leaf extract, and Astragalus root extract is present
in an amount from 125 mg to 750 mg.
8. (canceled)
9. The composition of claim 1, wherein each of L-lysine, Elderberry
extract, olive leaf extract, and Astragalus root extract is present
in an amount from 125 mg to 250 mg.
10. The composition of claim 1, wherein the amount of BC30 is
1.times.10.sup.8 to 1.times.10.sup.12 CFU.
11. (canceled)
12. The composition of claim 1, wherein the amount of BC30 is 2
billion CFU.
13. A method for improving the quality of life in a subject
diagnosed with ASD, which comprises administering a therapeutically
effective dose of an antiviral compound to the subject and
administering the supplement composition of claim 1 to the subject,
wherein the method leads to improvement in ASD symptoms,
improvement in the subject's behavioral performance, improvement in
the signs and symptoms of infection in the subject, and/or
improvement in the subject's overall immune health.
14. The method of claim 12, wherein the antiviral compound is
selected from the group consisting of: valacyclovir, acyclovir,
ganciclovir and famciclovir.
15. The method of claim 13, wherein the antiviral compound is
valacyclovir.
16. The method of claim 12, further comprising, prior to
administration of the antiviral compound, diagnosing the subject
with ASD.
17. The method of claim 12, further comprising, prior to
administration of the antiviral compound, testing the subject for a
viral infection and/or testing the state of the subject's immune
health.
18. The method of claim 17, wherein the subject tests positive for
one or more viral infections and/or immunocompromising
conditions.
19. The method of claim 12, wherein the subject is sixteen years of
age or younger.
20-21. (canceled)
22. The method of claim 20, wherein the dose of antiviral compound
is 125 mg, and wherein the supplement composition comprises 2
billion CFU of BC30 and 125 mg each of L-lysine, Elderberry
extract, olive leaf extract and Astragalus root extract.
23-24. (canceled)
25. The method of claim 12, wherein the supplement composition is
administered to the subject orally.
26. A method for improving the quality of life in a subject
diagnosed with ASD, which comprises administering to the subject a
therapeutically effective amount of the composition of claim 1.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to U.S. Provisional Patent
Application, Ser. No. 62/551,557, filed Aug. 29, 2017, which is
incorporated herein by reference in its entirety.
BACKGROUND OF INVENTION
[0002] Autism spectrum disorder (ASD) refers to a group of
neurodevelopment disorders, including autistic disorder (autism),
Asperger syndrome, childhood disintegrative disorder, and pervasive
developmental disorders, which are characterized by repetitive,
distinctive patterns of behavior and difficulties with social
communication and interaction. Subjects with ASD may have a
combination of many symptoms and syndromes, which are typically
present from early childhood and affect daily functioning.
[0003] Included within ASD is a wide range of symptoms, skills, and
levels of functional disability. Some children and adults with ASD
are fully capable of performing all activities of daily life, while
others require substantial support to perform basic life functions
and activities. Additionally, individuals with ASD may experience
pathologic changes such as brain inflammation, gastrointestinal
problems, immune system imbalance, lipid metabolism imbalance, and
possible increased risk of cancer due to links between autism and
mutations in cancer-associated genes and pathways.
[0004] The prevalence of ASD in children in the United States has
been increasing rapidly over the past 50 years. At present, the
rate of ASD prevalence is 1 case for every 59 children born.
Compared to 2016, when it was 1 in 68 children; 2008, when it was 1
in 125 children; and 50 years ago, when it was 1 in 2500 children,
the present statistics indicate that ASD prevalence is not only
increasing, but actually doubling every ten years.
[0005] Considerably more males are affected with ASD than females.
For some individuals, the core symptoms of ASD (i.e., impairments
in communication and social interaction, and restricted/repetitive
behaviors and interests) may improve with intervention and
maturation; however, core deficits typically translate into varying
developmental presentations that endure throughout the
lifespan.
[0006] The exact cause of ASD development is not entirely clear,
and the underlying root of ASD symptoms, such as damaged brain
structures and impaired nerve connections, cannot be readily
corrected by existing medications. However, drugs useful in
treating other diseases with similar symptoms can be useful in
managing ASD, though none have been approved by the FDA for
treating ASD specifically.
[0007] It is known that ASD does have a strong genetic component,
with heritability estimated to be as high as 90% in some studies.
Identification of specific genetic risk variants has proved to be
challenging, however, and many researchers suggest that there may
be multiple pathways to the disorder, with prenatal and postnatal
insult potentially contributing to its development in some
instances. For example, certain metabolic and other maternal
conditions (e.g., diabetes, hypertension, obesity and infection),
as well as consumption of alcohol and certain medications (e.g.,
antidepressants) during pregnancy may be associated with increased
risk of ASD in offspring.
[0008] Additionally, maternal immune malfunction during pregnancy,
including chronic immune activation of microglia, may also cause
some alterations in a child's brain. The connection is explained by
possible upregulation of brain inflammatory cytokines resulting
from immune activation in the mother, which then leads to presence
of these cytokines in sera and frontal and cingulate cortices of
the fetal brain. This is thought to affect the course of brain
development, which may lead to ASD.
[0009] Much of the research into ASD etiology points to congenital
chronic infections as a cause for development of the disorder. Many
of these infections are viral, including Herpes Simplex Virus (HSV)
1 and 2, Human Herpes Virus (HHV) 6, Epstein-Barr Virus, Rubella
virus, Measles virus, Cytomegalovirus (CMV), BK virus, JK virus,
SV40 virus, and others.
[0010] For example, it was reported in 2005 that in the USA,
approximately 40,000 children are born with congenital
cytomegalovirus (CMV) infection, and Binda et al. found that
congenital CMV was found 10 times more often in blood of children
with ASD than in healthy children. Human herpes virus-6 was found
in children with ASD 3.5 times more often than within healthy
children. Epstein-Barr virus (EBV) was found in patients with
multiple sclerosis and ASD. Congenital rubella syndrome caused by
transmission of rubella virus from mother to fetus also strongly
affects the brain development, and children with ASD are infected
200 times more often than healthy children. Additionally, the
combination of three viruses: BK virus, JC virus and simian virus
40 was found two times more often in children with ASD than in
healthy controls.
[0011] Furthermore, the roles of herpes simplex viruses (HSV) 1 and
2 in influencing the development of a number of neurodevelopmental
disorders, including schizophrenia, Alzheimer's disease, epilepsy,
and ASD have also been studied.
[0012] The mechanism by which viral infection may lead to autism is
not yet clear. One theory is that, once a subject is infected, many
viruses have the ability to localize in certain brain sections, or
through infection elsewhere in the body, trigger disease in the
central nervous system. This might in turn disturb normal brain
development. The mechanism may also occur through immune responses
in the mother while a fetus is developing, which may lead to
weakening of the fetus's immune system and further lead to
disturbances in brain development.
[0013] There is no cure for ASD, but current therapies and
behavioral interventions exist, which are designed to improve
certain symptoms of the disorder; however, most existing treatments
focus on treating the brain and cognitive functions specifically,
rather than the other potential underlying causes of ASD and its
symptoms. For example, repetitive transcranial magnetic stimulation
(rTMS) is a type of brain stimulation therapy that has been tested
as a treatment tool for various neurological and psychiatric
disorders, including migraines, strokes, Parkinson's disease,
dystonia, tinnitus, depression, and auditory hallucinations, where
a coils is placed near the patient's head to depolarize or
hyperpolarize neurons of the brain. In particular, rTMS uses
electromagnetic induction to induce weak, repetitive electrical
currents using a rapidly changing magnetic field to cause activity
in desired brain regions. While this may produce short-term relief
from certain cognitive and brain-related symptoms, it does not
treat, for example, compromised immune health underlying a
neurodegenerative condition.
[0014] The ideal treatment plan for a subject diagnosed with ASD
coordinates therapies and interventions that meet the specific
needs of the individual, based on where he or she falls on the
spectrum. Most health care professionals agree that the earlier the
intervention, the better.
[0015] Thus, there is a continuing need for new, integrated
compositions and methods for treating a broad range of ASD symptoms
and improving the overall quality of life and performance for
patients--particularly children--diagnosed with autism and its
spectra.
BRIEF SUMMARY
[0016] The present invention provides compositions and methods for
improving cognitive, immune and/or digestive functioning in
subjects with autism spectrum disorder (ASD) and other
immunocompromising conditions. Advantageously, embodiments of the
present invention provide compositions and methods for modulating
the immune system and improving the quality of life for subjects,
particularly children, with ASD.
[0017] In certain embodiments, the present invention provides a
supplement composition for improving the quality of life for a
subject diagnosed with ASD, wherein the composition comprises
ingredients that help support immune health and suppress infectious
agents in the subject's body. Additionally, a majority, if not all,
of these ingredients can be natural or naturally-derived.
[0018] In one embodiment, the subject invention provides a
supplement composition that comprises L-Iysine, Elderberry extract,
olive leaf extract, Astragalus root extract, and Bacillus coagulans
GBI-30 probiotic (BC30).
[0019] In a further embodiment the supplement composition
comprises, consists of, or consists essentially of L-lysine,
Elderberry extract, olive leaf extract, Astragalus root extract,
and Bacillus coagulans BC30.
[0020] In preferred embodiments, the supplemental composition is
used in conjunction with an antiviral agent such as, for example,
valacyclovir
[0021] Thus, in one embodiment, the present invention provides a
method for improving the quality of life for a subject diagnosed
with ASD or another immunocompromising condition, wherein the
method comprises administering to the subject
therapeutically-effective amounts of an antiviral compound and a
supplement composition of the present invention.
[0022] In one embodiment, the method can be used to treat symptoms
of ASD, including behavioral, mental, emotional and/or
physiological symptoms.
[0023] The antiviral compound can include prescription drugs and/or
naturally-derived treatments. Preferably, the antiviral compound is
a prescription drug selected from common drug compounds
valacyclovir, acyclovir, famciclovir, ganciclovir, valganciclovir,
ribavirin, brivudin, cidofovir, fomivirsen, foscarnet, penciclovir,
vidarabine and others used to treat chronic, congenital,
persistent, latent, dormant, acute and/or subacute viral
infections.
[0024] In one embodiment, the method first comprises testing the
subject for and/or diagnosing the subject with ASD and/or another
immunocompromising condition, such as a viral infection. In one
embodiment, the method can first comprise testing the subject for
signs of poor immune health, for example, by testing the subject
for immune marks such as T-cells and NK cells. In one embodiment,
the testing is performed using known blood testing methods.
[0025] In one embodiment, the subject being treated according to
the present invention has previously contracted an infection,
currently has an infection, or has been exposed to one or more
infectious agents. In preferred embodiments, the infection is due
to a chronic virus.
[0026] In one embodiment, the subject is diagnosed specifically
with autistic disorder or autism. In on embodiment, the subject is
diagnosed with one or more of cytomegalovirus, Epstein-Barr virus,
rubella virus, measles virus, herpes simplex type 1 or 2, herpes
zoster, other herpes family viruses, or any other chronic,
congenital, persistent, latent, dormant, acute and/or subacute
viral infection.
[0027] The subject of the present invention can be any human
diagnosed with an immunocompromising condition and/or with ASD. In
one embodiment, the human subject is a child or adolescent, for
example, 16 years of age or younger.
[0028] Advantageously, the present invention can improve the
quality of life for immunocompromised subjects who are diagnosed
with, for example, ASD and/or a viral infection. The present
invention can lead to simultaneous improvement of mental, emotional
and physiological symptoms of ASD, improvement in behavioral
performance, and improvement in sign and symptoms of viral
infections.
BRIEF DESCRIPTION OF THE FIGURE
[0029] FIG. 1 shows an example of a questionnaire given to parents
of children diagnosed with ASD prior to undergoing a treatment
according to the subject invention.
DETAILED DISCLOSURE
[0030] The present invention provides compositions and methods for
treating subjects with an autism spectrum disorder (ASD) and/or an
immunocompromising condition. Advantageously, the subject invention
can improve the immune health and overall quality of life of a
subject--particularly a child--diagnosed with ASD and/or an
immunocompromising condition.
Selected Definitions
[0031] The terms "autism spectrum disorder" and "ASD" are used in
this disclosure to refer to a spectrum of disorders characterized
by abnormalities of social interactions and communication, as well
as restricted interests and repetitive behavior. This spectrum
includes, but is not limited to, autistic disorder (autism),
Asperger's syndrome, childhood disintegrative disorder, atypical
autism or pervasive developmental disorder not otherwise specified
(PPD-NOS), as well as Rett syndrome and tuberous sclerosis.
[0032] As used herein, "treating" or "treatment" means the
eradicating, improving, reducing, ameliorating or reversing of at
least one sign or symptom of a condition or disorder. Treatment can
include, but does not require, a complete cure of the condition or
disorder, meaning treatment can also include partial eradication,
improvement, reduction, amelioration or reversal. Treatment can
also include delaying, forestalling and/or inhibiting the
progression of a condition or disorder to a more severe condition
or disorder.
[0033] Signs and/or symptoms encompass those of ASD or of any
comorbidity of ASD. Signs and symptoms associated with ASD include,
but are not limited to irritability; hyperactivity; inattention;
abnormalities in speech, verbal, communication, and language
skills; repetitive behavior, including stereotypy, compulsive
behavior, sameness (resistance to change), and ritualistic
behavior; obsessive focus on certain topics and/or objects;
inability to make eye contact; abnormalities in social interactions
and/or understanding of others' feelings; anger issues and/or
emotional outbursts; self-injury; and others.
[0034] Comorbidities of ASD include but are not limited to anxiety;
attention deficit disorder; brain inflammation; viral infections;
clinical depression; Tourette syndrome; Fragile X syndrome;
obsessive-compulsive disorder; bipolar disorder; learning
disabilities; sensory disorders; developmental coordination
disorder; disorders of the immune system and/or gastrointestinal
system, including candidiasis; seizures and/or epilepsy; sleep
disorders; increased risk of cancer; and others.
[0035] The terms "therapeutically effective" amount or dose,
"effective amount," and "effective dose" are used in this
disclosure to refer to an amount of a compound or composition that,
when administered to a subject, is capable of providing a desired
therapeutic effect or a desired level or treatment. The actual
amount of the compound or composition will vary depending on a
number of factors including, but not limited to, the particular
disorder being treated, the severity of the disorder, the size and
health of the patient, and the route of administration. A skilled
medical practitioner can readily determine the appropriate amount
using methods known in the medical arts.
[0036] A plant "extract," as used herein, refers to the material
resulting from exposing a plant part to a solvent and removing the
solvent, or from using various chemical, immunological, biochemical
or physical procedures known to those of skill in the art,
including but not limited to, precipitation, centrifugation,
filtering, column chromatography, and detergent lysis. Plant
material can include roots, stems, leaves, flowers, or parts
thereof.
[0037] As used herein, the term "probiotic" refers to
microorganisms, which, when administered in adequate amounts,
confer a health benefit on the host. The probiotics may be
available in foods and dietary supplements (for example through
capsules, tablets, and powders). Non-limiting examples of foods
containing probiotics include dairy products such as yogurt,
fermented and unfermented milk, smoothies, butter, cream, hummus,
kombucha, salad dressing, miso, tempeh, nutrition bars, and some
juices and soy beverages. In preferred embodiments, the
microorganisms are live.
[0038] The terms "natural" and "naturally-derived," as used in the
context of a chemical compound or substance is a material that is
found in nature, meaning that it is produced from earth processes
or by a living organism. A natural product can be isolated or
purified from its natural source of origin and utilized in, or
incorporated into, a variety of applications, including foods,
beverages, cosmetics, and supplements. A natural product can also
be produced in a lab by chemical synthesis, provided no artificial
components or ingredients (i.e., synthetic ingredients that cannot
be found naturally as a product of the earth or a living organism)
are added.
[0039] The terms "isolated" or "purified," when used in connection
with biological or natural materials such as nucleic acid
molecules, polynucleotides, polypeptides, proteins, organic
compounds, such as small molecules, microorganism cells/strains, or
host cells, means the material is substantially free of other
compounds, such as cellular material, with which it is associated
in nature. That is, the materials do not occur naturally without
these other compounds and/or have different or distinctive
characteristics compared with those found in the native
material.
[0040] In certain embodiments, purified compounds are at least 60%
by weight the compound of interest. Preferably, the preparation is
at least 75%, more preferably at least 90%, and most preferably at
least 99% or 100% (w/w) of the desired compound by weight. Purity
is measured by any appropriate standard method, for example, by
column chromatography, thin layer chromatography, or
high-performance liquid chromatography (HPLC) analysis.
[0041] The description herein of any aspect or embodiment of the
invention using terms such as "comprising," "having," "including,"
or "containing" with reference to an element or elements is
intended to provide support for a similar aspect or embodiment of
the invention that "consists of," "consists essentially of," or
"substantially comprises" that particular element or elements,
unless otherwise stated or clearly contradicted by context (e.g., a
composition described herein as comprising a particular element
should be understood as also describing a composition consisting of
that element, unless otherwise stated or clearly contradicted by
context).
[0042] The term "consisting essentially of," as used herein, limits
the scope of the ingredients and steps to the specified materials
or steps and those that do not materially affect the basic and
novel characteristic(s) of the present invention.
Supplement Compositions
[0043] In certain embodiments, the present invention provides a
supplement composition for improving the quality of life for a
subject diagnosed with ASD or another immunocompromising condition,
wherein the supplement composition comprises ingredients that help
support immune health and suppress infectious agents in the
subject's body. Additionally, a majority, if not all, of these
ingredients can be natural or naturally-derived.
[0044] In one embodiment, the supplement composition comprises
L-lysine, Elderberry extract, olive leaf extract, Astragalus root
extract, and Bacillus coagulans GBI-30 probiotic (BC30).
[0045] In a further embodiment the supplement composition
comprises, consists of, or consists essentially of L-lysine,
Elderberry extract, olive leaf extract, Astragalus root extract,
and Bacillus coagulans BC30.
[0046] In one embodiment, the supplement composition helps support
the immune system of a subject with a compromised immune system,
for example, a subject diagnosed with ASD and/or a viral infection.
As used herein, the term "support" can include boosting, improving,
enhancing, and/or maintaining the proper functioning of a body
system, for example, those involved in the immune system.
[0047] Immune support can include support for the cells, tissues,
and organs that contribute to proper functioning of the immune
system, for example, the lymphatic system, spleen, bone marrow, or
any other system involved in production of entities (e.g.,
antibodies, lymphocytes, red blood cells, white blood cells,
platelets) that ward off foreign substances (e.g., inoculants such
as bacteria, viruses, parasites, and fungi) from the body's normal
and healthy tissues. Immune support can further include support for
parts of the body that aid in preventing and healing from injury,
inflammation, cancer, or other non-infectious diseases, ailments,
or conditions.
[0048] In some aspects, the supplement composition can also help
support other body systems that are known to be interrelated with
immune health, such as the circulatory, endocrine, urinary,
muscular, respiratory, skeletal, central nervous, digestive,
integumentary, and reproductive systems.
[0049] In other words, the subject composition can be effective in
supporting more than one body system, particularly where the health
of one body system promotes the health of another.
[0050] In one embodiment, L-lysine is present in the supplement
composition in amounts up to 750 mg, up to 500 mg, up to 250 mg or
up to 125 mg.
[0051] L-lysine is an essential amino acid found naturally in, for
example, meats, beans, cheeses, eggs and other casein-containing
foods. It is important for proper growth, muscle protein building
and metabolism, and can be effective in reducing anxiety, mood
disturbances and headaches. Furthermore, L-lysine reduces the
cyto-pathogenicity of HSV through reduction in the herpes virus
load.
[0052] In one embodiment, Elderberry extract is present in the
supplement composition in amounts up to 750 mg, up to 500 mg, up to
250 mg or up to 125 mg.
[0053] Elderberry extract comprises extract from the fruit and/or
flowers of plants of the black elder plant (Sambucus nigra). It is
a well-known immune-boosting substance containing anthocyanins,
flavonoids, vitamins, minerals and antioxidants. Elderberry extract
has been shown to alleviate allergies, protect against certain
infections such as cold and flu viruses, reduce toothaches and
headaches, moderate digestion, and exhibit activity against HSV 1.
Furthermore, the flavonoids and anthocyanins in elderberry extract
provide anti-inflammatory, anti-oxidant and immunostimulatory
properties.
[0054] In one embodiment, olive leaf extract (Olea europaea) is
present in the composition in amounts up to 750 mg, up to 500 mg,
up to 250 mg or up to 125 mg.
[0055] Olive leaf extract is well known as a multi-functional
alternative treatment for many diseases and conditions. The
chemical compounds found in olive leaf extracts, including
polyphenols, flavonoids, oleuropein, tyrosol, and hydroxytyrosol,
and more particularly the active ingredient elenolic acid, have
antibacterial, antioxidant, antiviral, neuroprotective and
antifungal properties, thereby making olive leaf extract effective
in fighting a wide range of diseases, including: influenza, EBV,
CMV, common cold, bacterial/viral meningitis, postsurgical
infections, kidney infections, shingles, hepatitis, pneumonia and
malaria. Additionally, olive leaf can affect the down-regulation of
genes that participate in inflammatory processes, thus making it a
useful anti-inflammatory compound. Furthermore, olive leaf extract
is through to be effective for regulation of lipid and carbohydrate
metabolism as well as hypoglycemia.
[0056] In one embodiment, Astragalus root extract is present in the
composition in amounts up to 750 mg, up to 500 mg, up to 250 mg or
up to 125 mg.
[0057] Astragalus root extract can be obtained from the roots of an
Astragalus plant species, including, for example, Astragalus
membranaceus. This extract has antibacterial, antiviral,
anti-inflammatory, antioxidant, anti-aging, and anti-cancer
properties. Furthermore, Astragalus intake enhances production of
immune system cells and stimulation of growth of stem cells.
[0058] In one embodiment, Bacillus coagulans GBI-30 probiotic
("BC30") is present in the composition in amounts from
1.times.10.sup.8 to 1.times.10.sup.12 CFU, preferably
1.times.10.sup.9 to 1.times.10.sup.11 CFU, and more preferably 2
billion CFU.
[0059] BC30 has been shown to promote digestive health, aide in
reducing inflammation, and regulate imbalances in lipid metabolism
and the immune system. Moreover, BC30 intake can increase immune
response to viral agents, such as influenza A virus and adenovirus
and inhibit some herpes family viruses.
[0060] BC30 is a preferred probiotic for the present invention
because it is capable of surviving the acidity of the stomach, thus
allowing it to reach the intestines. BC30 contains a natural
protective layer of proteins, which allows it to not only survive
the harsh environment of the stomach, but also allows it to survive
most manufacturing processes. Moreover, BC30 may also out-compete
other harmful bacteria that cause infections or may have other
deleterious effects. BC30 may delay the onset of symptoms and
promote quicker recovery from infection and/or colitis caused by
Clostridium dificile. BC30 may also be helpful in replenishing
beneficial bacteria in the intestines for individuals who have been
prescribed antibiotics.
Formulation and Delivery of Supplement Compositions
[0061] In a preferred embodiment, the supplement composition of the
present invention is formulated so that it can be delivered to a
subject orally. In particular, the composition is formulated as an
orally-consumable product.
[0062] Orally-consumable products according to the invention are
any preparations or compositions suitable for consumption, for
nutrition, for oral hygiene or for pleasure, and are products
intended to be introduced into the human or animal oral cavity, to
remain there for a certain period of time and then to either be
swallowed (e.g., food ready for consumption) or to be removed from
the oral cavity again (e.g. chewing gums or products of oral
hygiene or medical mouth washes). These products include all
substances or products intended to be ingested by humans or animals
in a processed, semi-processed or unprocessed state. This also
includes substances that are added to orally-consumable products
(e.g., active ingredients such as extracts, nutrients, supplements,
or pharmaceutical products) during their production, treatment or
processing and intended to be introduced into the human or animal
oral cavity.
[0063] Orally-consumable products can also include substances
intended to be swallowed by humans or animals and then digested in
an unmodified, prepared or processed state. These include casings,
coatings or other encapsulations that are intended also to be
swallowed together with the product or for which swallowing is to
be anticipated.
[0064] Preferably, the orally-consumable product according to the
invention is formulated as a composition to be consumed for
nutrition or pleasure. These particularly include baked goods
(e.g., bread, dry biscuits, cake, cookies, brownies and other
pastries), sweets and candies (e.g., chocolates, chocolate bar
products, other bar products, gummies, fruit leathers, jelly beans,
coated tablets, hard candies, toffees and caramels, and chewing
gum), non-alcoholic beverages (e.g., cocoa, coffee, green tea,
black tea, herbal teas, lemonades, isotonic beverages, soft drinks,
nectars, fruit and vegetable juices, and fruit or vegetable juice
preparations), instant beverages (e.g., instant cocoa beverages,
instant tea beverages, instant smoothies, instant milkshakes and
instant coffee beverages), meat products (e.g., cold cuts, fresh or
raw sausage preparations, seasoned oder, marinated fresh meat or
salted meat products), eggs or egg products (e.g., dried whole egg,
egg whites, and egg yolks), cereal products (e.g., breakfast
cereals, muesli bars, and pre-cooked instant rice products), dairy
products (e.g., whole fat or fat reduced or fat-free milk
beverages, rice pudding, yoghurt, kefir, cream cheese, soft cheese,
hard cheese, dried milk powder, ice cream, sherbet, whey, butter,
buttermilk, and partly or wholly hydrolyzed products containing
milk proteins), products produced from nuts (e.g., nut milks, nut
butters, nut flours or powders), products from soy protein or other
soy bean fractions (e.g., soy milk and products prepared thereof,
beverages containing isolated or enzymatically treated soy protein,
soy flour containing beverages, preparations containing soy
lecithin, fermented products such as tofu or tempeh products
prepared thereof and mixtures with fruit preparations and,
optionally, flavoring substances), fruit preparations (e.g., jams,
fruit ice cream, fruit sorbets, fruit smoothies, fruit sauces, and
fruit fillings), vegetable preparations (e.g., ketchup, sauces,
dried vegetables, deep-freeze vegetables, pre-cooked vegetables,
and boiled vegetables), snack articles (e.g., chips, crisps,
pretzels, biscuits, crackers and nuts), products on the basis of
fat and oil or emulsions thereof (e.g., mayonnaise, remoulade, and
dressings), other ready-made meals and soups (e.g., dry soups,
instant soups, and pre-cooked soups), seasonings (e.g., sprinkle-on
seasonings), sweetener compositions (e.g., tablets, sachets, and
other preparations for sweetening beverages or other food). The
present compositions may also serve as semi-finished products for
the production of other compositions intended for nutrition or
pleasure.
[0065] Preferably, the present composition is delivered by an
orally-consumable product that appeals to children, for example, in
the form of a sweet treat or snack. In a preferred embodiment, the
composition is delivered in the form of a chocolate bar, a gummy or
a jelly.
[0066] When formulated as a chocolate bar, the chocolate can be
dark chocolate, light chocolate, milk chocolate, white chocolate or
a mixture thereof. Optionally, caramel, nut butters, fruit or fruit
fillings, coconut, sprinkles, chips (chocolate or other), candies,
or any of a variety of other flavorings or food products can be
added to the bar to enhance the taste and appeal thereof.
[0067] Preferably, the chocolate bars are packaged in blister
packs, or in larger, multi-dose break-apart bars with individual
sections constituting one dose. The chocolate bars can also be
packaged as individually wrapped single-dose bars.
[0068] In certain embodiments, the composition is formulated as a
gummy or a jelly, or some other form of gelatinous or chewy candy.
For example, the composition can be formulated as a gummy bear,
gummy worm, or other well-known gummy candy, a fruit snack, a fruit
tape, a fruit leather, a jelly bean or a taffy. A single dose of
the supplement composition can be included in one piece of the
candy, or divided between a pre-determined number of candies, for
example from 2 to 5 pieces.
[0069] The composition of the subject invention can also be present
in the form of capsules, tablets (uncoated and coated tablets,
e.g., gastro-resistant coatings), coated tablets, granules,
pellets, solid-substance mixtures, dispersions in liquid phases, as
emulsions, powders, solutions, pastes or other swallowable or
chewable preparations, or as a dietary supplement.
[0070] For oral administration, tablets or capsules can be prepared
by conventional means with acceptable excipients such as binding
agents, fillers, lubricants, disintegrants, or wetting agents. The
tablets can be coated, if desired. Liquid preparations for oral
administration can take the form of, for example, solutions,
syrups, or suspension, or they can be presented as a dry product
for constitution with saline or other suitable liquid vehicle
before use.
[0071] The compositions described herein can also contain
acceptable additives as will be understood by one skilled in the
art, depending on the particular form of the delivery method.
Non-limiting examples of such additives include suspending agents,
emulsifying agents, non-aqueous vehicles, preservatives, buffer
salts, flavoring, coloring, and sweetening agents as appropriate.
Non-limiting examples of specific additives include: gelatin,
glycerin, water, beeswax, lecithin, cocoa, caramel, titanium
dioxide, and carmine. Preparations for oral administration also can
be suitably formulated to give controlled release of the active
ingredients.
[0072] In some cases, the composition provided herein can contain
an acceptable carrier for administration to a human subject or
other mammal including, without limitation, sterile aqueous or
non-aqueous solutions, suspensions, and emulsions. Examples of
non-aqueous solvents include, without limitation, propylene glycol,
polyethylene glycol, vegetable oils, and organic esters. Aqueous
carriers include, without limitation, water, alcohol, saline, and
buffered solutions. Acceptable carriers also can include
physiologically acceptable aqueous vehicles (e.g., physiological
saline) or other known carriers appropriate to specific routes of
administration.
Methods for Improving the Quality of Life in Immunocompromised
Subjects
[0073] The present invention further provides a method for
improving the quality of life for a subject diagnosed with ASD or
another immunocompromising condition, wherein the method comprises
administering to the subject a therapeutically-effective dose of an
antiviral compound and a supplement composition of the present
invention.
[0074] Advantageously, the present invention can improve the
quality of life for immunocompromised subjects who are diagnosed
with, for example, ASD and/or an infection. In other words, the
present invention can lead to simultaneous improvement of, for
example, the mental, emotional and physiological symptoms of ASD,
improvement in behavioral performance, improvement in the signs and
symptoms of infections, and improvement in the overall immune
health of the subject.
[0075] In one embodiment, the method can be used to improve
symptoms of ASD, including behavioral, mental, emotional and/or
physiological symptoms.
[0076] The subject of the present invention can be any human
diagnosed with ASD or exhibiting the signs and symptoms thereof. In
one embodiment, the human subject is a child or adolescent, for
example, 16 years of age or younger.
[0077] In one embodiment, the subject is a child diagnosed with ASD
or who exhibits the signs and symptoms thereof. In another
embodiment, the subject has a compromised immune system, for
example, due to genetics, illness, or because the subject
previously contracted or was exposed to a viral or bacterial
infection. The subject may presently be exhibiting signs of
infection, or the subject may be asymptomatic because, for example,
contraction of the virus occurred at some time in the past, e.g.,
in utero.
[0078] In specific embodiments, the subject has contracted or been
exposed to a viral infection thought to be associated with
alteration of immune system functioning and/or development of ASD,
including but not limited to the following long-term or chronic
viruses: cytomegalovirus (CMV); Rubella virus; measles virus;
varicella zoster virus (VZV); Epstein-Barr virus (EBV), herpes
simplex virus types 1 and 2 (HSV); human herpes virus (HHV); BK
virus (BKV); JC virus (JCV); and simian virus 40 (SV40).
[0079] Viral infection or exposure according to the subject
disclosure typically occurs early on in a subject's development,
either through vertical transmission (i.e., from mother to embryo,
fetus, or infant during pregnancy or childbirth), direct
transmission (i.e., contact from another infected subject), or
indirect transmission (e.g., through a vector).
[0080] In some embodiments, the method comprises the step of
diagnosing the subject with ASD prior to administering the
antiviral to the subject. In further embodiments, the method
comprises, the step of testing the subject for infection or signs
of exposure to an infection prior to administering the antiviral to
the subject. This can be done using, for example, blood tests that
detect certain antibodies. In one embodiment, the method can also
comprise performing an immune analysis on the subject to test for
overall immune health and/or the presence of any immunocompromising
conditions.
[0081] According to one embodiment, the step of administering
antiviral treatment comprises administering a
therapeutically-effective dose of a prescription antiviral
medication. The antiviral compound according to the subject methods
can include prescription drugs and/or naturally-derived treatments.
Preferably, the antiviral compound is a prescription drug selected
from the commonly used drug compounds valacyclovir, acyclovir,
famciclovir, ganciclovir, valganciclovir, ribavirin, brivudin,
cidofovir, fomivirsen, foscarnet, penciclovir, vidarabine and
others used to treat chronic, congenital, persistent, latent,
dormant, acute and/or subacute viral infections.
[0082] In a preferred embodiment, the antiviral medication is
selected from the group consisting of valacyclovir (also known as
Valtrex), acyclovir (also known as Zovirax), ganciclovir (also
known as, e.g., Cytovene) and famciclovir (also known as
Famvir).
[0083] Each of these commercially available drugs was originally
designed for treatment of adults infected with herpes family
viruses. Valacyclovir, most commonly administered for treating and
suppressing genital herpes, can be given to patients with ASD to
suppress the herpes virus, if present, and decrease inflammation
and neurological dysfunction it causes. Valacyclovir can also be
useful in managing and/or treating herpes zoster (shingles),
cytomegalovirus, EBV, mononucleosis, and herpes B.
[0084] Valacyclovir is the prodrug of acyclovir, another common
antiviral treatment. Acyclovir differs from valacyclovir in that it
typically requires more frequent dosage.
[0085] Children with ASD may show improvements in any aspect of
their spectrum of symptoms in response to treatment with these
antiviral medications, including but not limited to improvement in
behavioral performance.
[0086] In embodiments of the present invention, administration of
the antiviral medication occurs daily for several months or longer.
Administration can include any known method of drug administration,
including, but not limited to, oral, nasal, cutaneous (e.g.,
applying it as a cream), or intravenous administration. In
preferred embodiments, administration is performed orally once or
twice daily.
[0087] The medication can be administered in cycles, for example,
four months on with two months off, or three weeks on with one week
off. Cycles can be repeated multiple times, for example three
times, or as many times as deemed necessary by a skilled
physician.
[0088] In a preferred embodiment, the antiviral treatment is
valacyclovir. Valacyclovir can be administered to the subject once
or twice a day, at up to 500 mg per dose, up to 250 mg per dose or
up to 125 mg per dose. Proper dosage of the antiviral treatment is
determined by a skilled physician based on the individual receiving
treatment, with factors such as age and symptoms considered.
[0089] In preferred embodiments, at the start of treatment, the
antiviral compound is administered to the subject on its own for
one week, two weeks or three weeks, to determine whether the
subject will experience any adverse side-effects from the
medication. Then, the supplement composition can be introduced into
the treatment while the antiviral treatment is continued.
[0090] In one embodiment, the supplement composition is ingested by
the subject once, twice, or three times per day, determined on a
subject-by-subject basis by a skilled physician. Factors to be
considered when determining the number of doses to administer
include the age of the individual receiving treatment and the
severity of his/her symptoms.
[0091] The concomitant administration of antiviral and supplement
composition can be continued for one or more consecutive cycles
lasting, for example, 21 days or longer. A cycle can be repeated as
many times as necessary without breaking in between, for example, 3
times or more. In one embodiment, the antiviral treatment can be
discontinued after a certain number of cycles, and administration
of the supplement composition can optionally be continued
indefinitely.
[0092] In one embodiment, the method comprises administering a
supplement composition comprising L-lysine, Elderberry extract,
olive leaf extract, Astragalus root extract, and Bacillus coagulans
GBI-30 probiotic (BC30).
[0093] In another embodiment, the method comprising administering a
supplement composition comprising, consisting of, or consisting
essentially of L-lysine, Elderberry extract, olive leaf extract,
Astragalus root extract, and Bacillus coagulans GBI-30 probiotic
(BC30).
[0094] More specifically, the method can comprise administering
L-Lysine in amounts up to 750 mg, up to 500 mg, up to 250 mg or up
to 125 mg; Elderberry extract in amounts up to 750 mg, up to 500
mg, up to 250 mg or up to 125 mg; olive leaf extract in amounts up
to 750 mg, up to 500 mg, up to 250 mg or up to 125 mg; Astragalus
root extract in amounts up to 750 mg, up to 500 mg, up to 250 mg or
up to 125 mg; and Bacillus coagulans GBI-30 probiotic (BC30) in
amounts up to 1.times.10.sup.12 CFU, more preferably 2 billion
CFU.
[0095] In one embodiment, the amount of each of L-Lysine,
Elderberry extract, olive leaf extract, and Astragalus root extract
is from about 125 mg to about 750 mg, from about 125 mg to about
500 mg, and/or from about 125 mg to about 250 mg. In one
embodiment, the amount of BC30 is from about 1.times.10.sup.8 CFU
to about 1.times.10.sup.12, from about 1.times.10.sup.9 to about
1.times.10.sup.11 CFU, or about 2 billion CFU.
[0096] In one embodiment, the subject undergoes periodic blood work
throughout the treatment time period, for example every week, every
month, or every two months. The blood testing can not only be used
to monitor the level of, for example, viral antibodies and/or viral
load in a subject, but also monitor how the subject's liver,
kidneys, blood cells and other body functions are operating. These
tests can serve as precautionary safeguards, as harmful side
effects from these treatments are rare or even nonexistent.
[0097] In some embodiments, the methods disclosed herein can also
include measuring a baseline of behavioral performance and/or
overall health prior to treatment of the subject according to the
subject methods, and/or measuring the behavioral performance and/or
overall health after treatment. The methods can include comparing
the behavioral performance and/or overall health prior to and after
treatment is administered to the subject, and the comparison can be
used to determine if and to what extent the behavioral performance
and/or overall health in the subject is improved, or if adjustments
should be made to the treatment given.
[0098] As used herein, the phrase "improvement in behavioral
performance" refers to reduction in the severity or frequency, to
whatever extent, of one or more of the behavioral disorders,
symptoms and/or abnormalities expressed by an individual suffering
from ASD, or a pathological condition having behavioral symptoms
similar to those of ASD. The improvement is either observed by the
individual taking the treatment themselves or by another person
(medical professional or otherwise).
[0099] In the method disclosed herein, behavioral performance can
be measured and evaluated using various parameters and methods. For
example, behavioral tests can be conducted to determine the
presence and/or extent of restricted repetitive behavior and/or
stereotyped behavior patterns of the subject under test. In some
embodiments, the Autism Behavior Checklist (ABC), Autism diagnostic
Interview-Revised (ADI-R), childhood autism Rating Scale (CARS),
and/or Pre-Linguistic Autism Diagnostic Observation Schedule
(PL-ADOS) is used for the behavioral test. The behavioral test can
include, but is not limited to, detecting the presence and/or
extent of (1) preoccupation with one or more stereotyped and
restricted patterns of interest that is abnormal in either
intensity or focus; (2) inflexible adherence to specific,
nonfunctional routines or rituals; (3) stereotyped and repetitive
motor mannerisms (such as hand flapping, finger flapping etc.);
and/or (4) persistent preoccupation with parts of objects.
Non-limiting examples of behavior that can be included in a
behavioral test and suggest a need for improving behavioral
performance in the subject under the test include:
[0100] (a) Sensory behaviors: poor use of visual discrimination
when learning; seems not to hear, so that a hearing loss is
suspected; sometimes shows no "startle response" to loud noise;
sometimes painful stimuli such as bruises, cuts, and injections
evoke no reaction; often will not blink when bright light is
directed toward eyes; covers ears at many sounds, squints, frowns,
or covers eyes when in the presence of natural light; frequently
has no visual reaction to a "new" person; stares into space for
long periods of time;
[0101] (b) Relating behaviors: frequently does not attend to
social/environmental stimuli; has no social smile; does not reach
out when reached for; non-responsive to others' facial
expressions/feelings; actively avoids eye contact; resists being
touched or held; is flaccid when held in arms; is stiff and hard to
hold; does not imitate other children at play; has not developed
any friendships; is often frightened or very anxious; "looks
through" people;
[0102] (c) Body and object use behaviors: whirls self for long
periods of time; does not use toys appropriately; insists on
keeping certain objects with him/her; rocks self for long periods
of time; frequently lunges and darts; flaps hands; walks on toes;
hurts self by banging head, biting hand, etc.; twirls, spins, and
bangs objects frequently; will feel, smell, and/or taste objects in
the environment; performs complicated "rituals" such as lining
things up; is very destructive; and
[0103] (d) Language behaviors: does not follow simple commands
given once; has pronoun reversal; speech is atonal; does not
respond to own name when called out among others; seldom says "yes"
or "I"; does not follow simple commands involving prepositions;
uses gestures to get desired objects; repeats phrases over and
over; cannot point to more than five named objects; uses 0-5
spontaneous words per day to communicate wants and needs; repeats
sounds or words over and over; echoes questions or statements made
by others; uses at least 15 but less than 30 spontaneous phrases
daily to communicate; learns a simple task but "forgets" quickly;
has strong reactions to changes in routine/environment; has
"special abilities" in one area of development, which seems to rule
out mental retardation; has severe temper tantrums and/or frequent
minor tantrums; hurts others by biting, hitting, kicking, etc.;
does not wait for needs to be met; has difficulties with toileting;
does not dress self without frequent help; is frequently unaware of
surroundings and may be oblivious to dangerous situations; prefers
to manipulate and be occupied with inanimate things; and a
developmental delay was identified at or before 30 months of
age.
[0104] One of ordinary skill in the art would appreciate that the
attending physician would know how to identify a subject in need of
treatment disclosed herein.
EXAMPLES
[0105] The examples described below illustrate exemplary
embodiments of the method of the subject invention. These exemplary
embodiments should not be construed as limiting the scope of the
subject invention.
Materials and Methods
[0106] Parents of children with confirmed ASD diagnoses were asked
to have the following tests performed on their children prior to
participating in the treatment study: (1) complete blood count; (2)
cellular immunity state (T-lymphocytes mature CD3+CD19, mature
T-lymphocytes CD3+CD19- abs, B-lymphocytes CD19+CD3-, B-lymphocytes
CD19+, T-helper cells CD3+CD4+T-helper cells CD3+CD4+ abs,
T-cytotoxic CD3+CD8+T-cytotoxic CD3+CD8+ abs, index T-helper
cells/cytotoxic CD4+/CD8+T-lymphocytes act of CD3+HLA-DR+, T-cells
act of CD3+HLA-DR+ abs, lymphocytes act of CD3-HLA-DR+, Lymphocytes
act CD3-HLA-DR+ abs, NK-cell CD3-CD16+/CD56+, NK-cell
CD3-CD16+/CD56+ abs, T-NK-cell CD3-CD16+/CD56+); and (3) antibody
tests (Epstein-Barr virus NA IgG, Epstein-Barr virus VCA IgM,
Cytomegalovirus IgG, Cytomegalovirus IgM, HSV 1,2 IgM, HSV 1,2 IgG,
Rubella IgM, Rubella IgG, Mycoplasma hominis IgG, Mycoplasma
hominis IgM, Mycoplasma pneumonia IgG, Mycoplasma pneumonia IgM,
Helicobacter pylori IgG, Chlamydia pneumonia IgG, and Chlamydia
pneumonia IgM).
[0107] The parents were then asked to fill in questionnaires (see
FIG. 1 for an example of questions asked) reflecting the presence
of the ASD symptoms and their severity. The questions related to,
for example, behavioral patterns and difficulties, level of
functioning, cognitive functioning, language ability, learning
impairment, comorbidities, physiological and psychological
condition (e.g., sleep disorders, epilepsy, gastrointestinal
issues, malfunction of the immune system, anxiety, depression
and/or hyperactivity). The severity of the symptoms was measured
using the ADI-R scale. (0-symptom is absent, 3--a symptom is
strongly pronounced).
[0108] The children were divided into three age groups: (1) 2-3
years old; (2) 3 to 7 years old; and (3) 7 years and older. The
treatment started with intake of valacyclovir for two weeks. The
supplement composition was added after the two week period, when
the absence of side-effects due to antiviral treatment was
confirmed.
[0109] For children of group (1), the valacyclovir dosage was 125
mg, twice a day. All supplements were prescribed at a dosage of 125
mg each, once a day, and probiotic BC-30 with dosage 2 billion
CFUs. One treatment cycle was 21 days long.
[0110] For children of group (2), the treatment scheme was the same
but with valacyclovir dosage increased to 250 mg, twice a day, and
supplement dosage increased to 250 mg each, once a day. BC-30
dosage remained at 2 billion CFUs.
[0111] For children of group (3), the valacyclovir dosage was
increased to 500 mg, twice a day, and supplement dosage increased
to 500 mg each, once a day. Again, BC-30 dosage remained at 2
billion CFUs.
[0112] For all three groups the scheme consisted of 3 consecutive
cycles, 21 days each, of daily valacyclovir treatment and
supplement intake.
[0113] Behavioral and comorbidity changes were observed in subjects
after treatment was underway for one month, as well as monitoring
of blood for viral antibodies and other immune responses.
[0114] Specific behavioral changes and improvements sought to be
observed were improvements in speech, language and verbal skills;
reduction in repetitive movements or unusual behaviors; reduction
of obsessive behavior; improvements in social interactions,
including ability to make eye contact with others; increased
interest in other children; improved understanding other people's
feelings or talking about own feelings; improved anger management
and reduction of emotional outbursts; and any others specific to a
particular child.
[0115] In addition, changes and improvements related to
comorbidities sought to be observed were reduced anxiety; improved
attention deficit; reduced hyperactivity; changes in clinical
depression; improved gastrointestinal symptomology; changes in
intellectual abilities; changes in obsessive behavior; reduction is
seizures and epileptic paroxysms; changes in sensory sensitivities;
and changes in sleep disorders.
Example 1--6-Year-Old Male "K. A."
[0116] Prior to treatment, the child's parents reported that the
child displayed the followed signs and symptoms of ASD: verbal
delays; unclear speech or spoke only learned phrases; did not
answer questions; could not express requests from others; exhibited
some stereotypical movements with hands; did not play with children
and toys or know how to join children's games; anger outbursts when
he did not get what he wanted; anxiety; hyperactivity; frequent
constipation; excessive sensitivity; hiding under his blanket; and
sleep problems.
[0117] The initial test for the presence of infections revealed EBV
IgG, CMV IgG, rubella IgG, and Helocobacter pylori IgG. The immune
analysis showed the decreased level of T-helpers, T-lymphocytes,
and IRI, and increased level of T-suppressors and NK cells. Blood
analysis identified the increased level of erythrocytes and
distribution of erythrocytes by volume.
[0118] After 1 month of the subject antiviral and supplement
therapy, the parents reported the following changes: 5-6 new words
appeared in the vocabulary; he started performing requests;
repeatability of movements and stims decreased; improvements in
understanding other people, including his mother; decreased anxiety
with a calmer demeanor; hyperactivity decreased slightly; and her
stopped hiding under his blanket.
[0119] Blood tests revealed the following physiological changes:
rubella IgG dropped by over 58% (from 106 to 62, ref. value 10),
CMV antibodies decreased by 12.6% (from 10.15 to 8.87, ref. value
1); T-helpers value returned to a normal value (from 25.14% to
43.6%, ref. value 30-50%), as well as T-lymphocytes (from 59.78 to
63%, ref value 60-80%), IRI (from 0.6 to 1.2, ref value 1.2-2), and
NK cells (from 25.81 to 16.7%, ref value 8-17%) (see Table 1).
TABLE-US-00001 TABLE 1 Changes in blood, immune and infectious
status in "K.A". Reference Before After 1 month Indices value
treatment of treatment EBV IgG 1 9.9 10.2 CMV IgG 1 10.15 8.87
Rubella IgG 10 106 62 Helicobacter Pylori 1.24 1.2 0 IgG T-helpers
30-50% 25.14% 43.6% T-lymphocytes 60-80% 59.78% 63% IRI 1.2-2 0.6
1.2 T-suppressors 18-25% 41.42% 37.8% NK cels 8-17% 25.81% 16.7%
Erythrocytes 10{circumflex over ( )}12/L 3.8-4.9 5.3 5.3
Distribution of 11.5-14.5% 15.8% 16 erythrocytes by volume
Example 2--12-Year-Old Male "A. T."
[0120] Prior to treatment, the child's parents reported that the
child displayed the followed signs and symptoms of ASD: speech
delays; repetition of certain words; unclear speech, only using
separate words; poor understanding of speech; exhibited some
stereotypical movements, including waiving of hands; difficulties
making eye contact; could not play with children because they did
not understand each other; and excessive focus on objects when he
wanted them (repeating the name of the object until he got it and
could not concentrate on anything else).
[0121] The initial test for the presence of infections revealed CMV
IgG, HSV IgG, Mycoplasma IgG, EBV IgG, and Helicobacter Pylori IgG.
Blood analysis identified the increased level of erythrocytes,
hematocrit, amount of hemoglobin, and distribution of erythrocytes
by volume.
[0122] After 1 month of the subject antiviral and supplement
therapy, the parents reported the following changes: the child
started to build sentences; he lost weight (from size L to M); new
words appeared in his vocabulary and he started speaking more and
more clearly; he started expressing verbally when he did not like
something; and his writing skills improved.
[0123] Blood tests revealed the following physiological changes:
antibodies to CMV became three times lower (from 68 to 21, ref
value 1); and mycoplasmas and Helicobater pylori disappeared. The
level of erythrocytes became lower and approached the normal level
(from 5.7. to 5.27, ref value 3.60-5.1), hematocrit reached a
normal value (from 45.4 to 42.5, ref value 34.5-42.5); and the
amount of hemoglobin reached normal (see Table 2).
TABLE-US-00002 TABLE 2 Changes in blood and infectious status in
"A.T." Reference Before After 1 month Indices value treatment of
treatment HSV IgG 1 6.74 9.7 CMV IgG 6 67.9 21 EBV IgG 0.8 11.47
15.93 Mycoplasma IgG 1 1.08 0 Helicobacter Pylori negative positive
negative IgG Amount of 26-31 pg 25.4 pg 27 pg hemoglobin in
erythrocytes Hematocrit 34.5-42.5% 45.4% 42.5% Erythrocytes 3.6-5.1
5.7 5.27 10{circumflex over ( )}12/L Distribution of 11.5-14.5%
17.4% 16.6% erythrocytes by volume
Example 3--4-Year-Old Male "A. R."
[0124] Prior to treatment, the child's parents reported that the
child displayed the followed signs and symptoms of ASD: absence of
speech (only one word in the vocabulary); stereotypical movements;
excessive focus on numbers and letters; minor difficulties in
communication with other children; aggressive behavior when he was
not allowed to do what he wanted; hyperactivity; and frequent
colds.
[0125] The test for the presence of infections revealed rubella
IgG. The blood test showed the increased level of erythrocytes and
hematocrit.
[0126] After 2 months of the subject antiviral and supplement
treatment, the parents reported the following changes: the child
started speaking with short sentences; he became more
communicative, for example, saying when he wanted something; he
started singing songs; there were 30 new words in his vocabulary;
he started looking into people's eyes when speaking to them and
tries to hold their hands; he became calmer; he cried less than
previously; he started understanding complex instructions,
including those having several consecutive actions; and during the
whole period of treatment he never contracted a cold.
[0127] Blood tests revealed the following physiological changes:
the level of erythrocytes decreased and approached to the normal
value (from 4.9 to 4.6, ref value 3.5-4.5), and hematocrit index
reached a normal value (from 40.8 to 39.3%, ref value 31-39.5%). At
the same time, the level of lymphocytes decreased from 21% to 40.9%
(ref value 25-60%), the level of neutrophils increased from 48.2%
to 71.3% (ref value 25-60%), and distribution of erythrocytes by
volume increased from 13.9% to 14.6% (ref value 11.5-14.5%) (see
Table 3).
TABLE-US-00003 TABLE 3 Changes in blood and infectious status in
"A.R." Reference Before After 1 month Indices value treatment of
treatment Rubella IgG 10 >500 >500 Erythrocytes 3.5-4.5 4.9
4.6 10{circumflex over ( )}12/L Hematocrit 31-39.5% 40.8% 39.3%
Lymphocytes 25-60% 40.9% 21% Neutrophils 25-60% 48.2% 71.3%
Distribution of 11.5-14.5% 13.9% 14.6% erythrocytes by volume
Example 4--5-Year-Old Male "I. Z."
[0128] I. Z. 5 year old boy had dramatically decreased speaking
ability, severe difficulties with social communication and
obsessive and fixated behavior diagnosed with "psycho-speech
development delay" at age of 2.8. parents complaints were "lack of
vocabulary, unwillingness to speak, difficulties in understanding
addressed speech, lack of interest in peers, fixations,
obsessiveness, anxiety and selectivity of food"
[0129] According to parents, pregnancy was complicated: prolonged
pregnancy, parturition through cesarean section, the child was born
with hypoxia. At the first months of life child was unusually quiet
and did not need attention.
[0130] Prior to the current treatment, the child attended
psychologist and defectologist, which resulted in some improvements
in communication and behavior, speech therapist, ABA therapy and
reflexotherapy.
[0131] Blood work. Lymphocytosis, increased hemoglobin, increased
mean corpuscular volume (MCV) and mean corpuscular hemoglobin
(MCH), neutropenia, detected IgG to CMV, EBV, HSV and rubella virus
over reference ranges, decreased T-helpers count, increased
B-lymphocytes count and T-lymphocytes count.
[0132] In 45 days the treatment was initiated: the level of
hemoglobin, MCV, MCH did not change did not change, the level of
lymphocytes decreased, the level of neutrophils increased, all
immune cells parameters became within reference ranges, HSV status
became negative, IgG to CMV, EBV, rubella virus reduced.
[0133] Moreover, more constructive speech appeared in the child's
speech, attempts to speak more, better understanding and
memorization. He became more initiative in classes, and less
aggressive. He started expressing pity, became more attached to
family members, and a sense of timing appeared. He also started
trying new types of food. During treatment, the appetite decreased,
and at the break appeared again.
Example 5--4-Year-Old Male "Y. S."
[0134] Y. S. 4 year old boy with significantly reduced speaking
ability, moderate problems with social communication, signs of
rituality and repetitive behavior, diagnosed with "speech
development delay with autistic patterns" at age of 3. Parents'
complaints were "few words in the speech, impaired eye contact,
lack of interest to peers, illogical statements in conversation,
ritual behavior, repetitive movements and frequent
constipations."
[0135] According to the parents, pregnancy was complicated--risks
of miscarriage several times during pregnancy. The child was
unusually quiet, rarely cried, had operation for hydrocele at age
of 7 months.
[0136] Prior to the subject treatment the child received the
following therapies: Tomatis therapy, ABA therapy, speech therapy,
body-oriented and exercise therapy, homeopathic therapy and
lactose-free and gluten-free diet. As a result, better
understanding, improved coordination, eye contact, more
independence.
[0137] Blood work: Monocytosis, decreased mean platelet volume
(MPV), increased erythrocytes sedimentation rate (ESD), detected
IgG to rubella virus and HSV over reference ranges, increased
T-lymphocytes and T-suppressors counts.
[0138] In 45 days the treatment was initiated: MPV did not change,
monocytes count decreased, became close to reference ranges, ESD
became within a reference range, IgG to rubella reduced, IgG to HSV
increased, all immune cells parameters became within reference
ranges.
[0139] Additionally the child began to speak more clearly, began to
fool around, began to do the rogueries (looks into eyes and
realizes that he made a mistake), tries to play with the computer,
began to joke, became more self-dependent, and more open. He
participated in a dialogue for the first time. His physical skills
improved, increased sociability in relation to other children, an
interest in spending time with children appeared. The stool became
more frequent.
Example 6--8-Year-Old Male "T. B."
[0140] T. B. 8 year old boy with significantly reduced speaking
ability, severe problems with social communication, repetitive and
restricted behavior of the severe level, and fixation, was
diagnosed with "atypical autism" at age of 4. The parents'
complaints were: "knows just few words, communicates through PECS
cards only, does not communicate with others, confuses emotions,
repetitive jumping and knocking, vocalizations, fixated interest to
some objects, hypersensitivity, anxiety, hyperactivity and frequent
respiratory infections".
[0141] The parents did not answer the questions regarding
pregnancy, parturition and first months of the child's life.
[0142] Prior to the treatment the child was treated by Valtrex and
Viferon, as a result he is getting sick more rarely, learned to
swim and to communicate through PECS cards. Later he was given
5-metylhydrofolate and Metylcobalamin B-12, which resulted in more
self-dependence. Supplements: NutraMedix Burbur-Pinella, Detox
Brain-Nerve Cleanse. The understanding of speech improved.
[0143] Blood work: Decreased MPV and MCV, monocytosis,
erythrocytosis, detected IgG to CMV and rubella virus, reduced
ratio T-helper/T-suppressor.
[0144] The treatment was initiated in 80 days: MPV decreased,
erythrocytes and MCV--within reference range, monocytes count did
not change, IgG to CMV and rubella virus slightly increased.
However, some blood cells changed beyond the normal values:
neutrophils decreased while eosinophils and lymphocytes increased.
The immune parameters were not tested.
[0145] The following changes were noticed by parents: He started to
understand requests and to communicate with other children, he says
"bye" to children when they finish playing and became more tender
and emotional to parents. the sleep significantly improved. Also
stool improved, constipation stopped. His resistance to respiratory
infections also improved.
Example 7--2.5-Year-Old Male "A. A."
[0146] A. A. 2.5 year old boy had significantly reduced speaking
ability, noticeable difficulties with social communication, mild
repetitive behavior, diagnosed with "delay in psycho-speech
development" and "attention deficit and hyperactivity disorder" at
age 1 year 4 months. Parents complaints were "few words in
vocabulary, inappropriate words in speech, impaired eye contact,
preference to stay alone, ignoring other people, periodical
repetitive movements".
[0147] Pregnancy and birth were not complicated, according to
parents. At 3 month the child had respiratory infection. At the
first year of life the child was very quiet, rarely cried. At 10
months the first symptoms were noticed--he did not react to the
name and became very hyperactive.
[0148] Prior to our therapy the following types of treatment were
applied: Cogitum, Cortexin, Multivitamins, herbal extracts
(echinacea, blueberry), probiotic Lysate and Omega 3; speech
therapy, psychological therapy, defectologist and play therapy;
bioacoustic correction. The parents did not indicate any changes
after these therapies.
[0149] Blood work: All white and red blood cells parameters were
within reference ranges, detected IgG to rubella over reference
range, decreased T-lymphocytes, T-helpers counts and reduced ratio
T-helper/T-suppressor, increased B-lymphocytes and T-suppressors
counts.
[0150] The treatment was initiated in 45 days: All immune cells
apart from T-suppressors became of a normal value, IgG to rubella
increased.
[0151] Additionally, parents reported that the vocabulary
increased, contact with other people improved, he started to react
to other people's questions and understands other people better.
Overall communication has improved repeatability of movements
decreased, became more interested in drawing.
Example 8--5-Year-Old Female "A. Z."
[0152] A. Z. 5 year old girl had moderate language impairment,
severe social communication problems, and severe restricted and
repetitive behavior, was diagnosed with "early organic damage to
the central nervous system, psycho-speech development delay,
organic-residual encephalopathy and ASD" at age of 2.7. Later the
diagnosis of atypical autism with mental retardation was
established at age of 4.6. The parents' complaints were: "limited
vocabulary, rare speech, impaired eye contact, absence of any
communication, difficulties in understanding addressed speech, no
expression of emotions, echolalia, repetitive behavior,
hypersensitivity, hyperactivity and selectivity of food."
[0153] According to parents, pregnancy was complicated: at the
first trimester there was a risk of miscarriage, bleeding, immature
birth at 36.sup.th week with hypoxia. After birth the child had
jaundice and was diagnosed with megalothymus. At the first year of
life-long sleep, was unusually calm, ignored people, was afraid of
noises.
[0154] Prior to our treatment the child took: Cortexin, Encephabol,
Pantocalcin, Noofen, Biomed. Glutamine, Gabu, enzyme for the
welding of gluten, Omega 3, and some vitamins and minerals; ABA
therapy; and gluten-free, casein-free, soy-free diet. The parents
did not notice significant results after these therapies.
[0155] Blood work: Increased RDW and ESD, detected IgG to EBV (NA),
CMV, and rubella virus over reference ranges, increased
T-suppressor count and decreased NK count.
[0156] In 80 days the treatment was initiated: RDW did not change,
ESD became of a reference range, neutrophils decreased below the
reference value, IgG to EBV reduced, IgG to rubella virus and CMV
did not change, T-suppressors increased--33.7%, NK cells became of
a reference value--13.8%, and T-helper count decreased below the
reference range.
[0157] Additionally, the parents reported that: the vocabulary
increased, the child started to build phrases, repeats some words
after mother. She became more responsive when people talk to her.
Eye contact became longer, she started playing with siblings.
Moreover, she became calmer, started studying at home, although
before she could not due to hyperactivity. She learned to use
toilet by herself and tried new types of food that she refused to
try before.
Example 9--5-Year-Old Male "O. D."
[0158] O. D. 5 year old boy had significantly reduced speaking
ability, severe problems with social communication, restricted
behavior and anxiety, diagnosed with ASD at age 2.5. Parents
complaints were: "only few words in vocabulary, rare usage of
speech, difficulties with understanding addressed speech and other
people's behavior, impaired eye contact, focusing on some objects,
anxiety about losing personal belongings and selectivity of
food."
[0159] According to parents, the pregnancy was complicated: at the
third trimester of pregnancy mother had respiratory infection. 3
months after birth the child had respiratory infection. Before age
of 1, he was unusually quiet, could sit and look at toys, or watch
cartoons, rarely smiled or laughed.
[0160] Prior to the antiviral treatment the child received the
following drugs and therapies: Ganglioside, Cortexin, Ceraxon,
Cerebrolysin, Gliatilin, Pantogam, Noofen, Mexidol, Encephabol;
biomethod (probiotics, supplements and gluten-free casein-free
diet), acupuncture and micropolarization. After all these
treatments the child became more hyperactive, but some new words
and phrases appeared in the speech.
[0161] Blood work: Neutropenia and increased ESD, detected IgG to
EBV (NA) and rubella virus over reference ranges, decreased T
lymphocytes, T-helper counts, reduced T-helper/T-suppressor ratio,
and increased T-suppressor and NK cells counts.
[0162] In 80 days the treatment was initiated: Neutrophils count
did not change; ESD became of a reference value; lymphocytes,
eosinophils, monocytes and basophils counts reduced below reference
ranges; IgG to EBV (NA) did not change; IgG to rubella reduced; and
T-suppressors, NK cells count, and ratio T-helpers/T-suppressors
did not change, all other immune cells became of a reference
ranges.
[0163] Additionally parents reported that: vocabulary increased,
for the first time he said the full sentence, he started using
words and phrases appropriately in the speech, communicative skills
improved, became more tender, expresses love towards family
members, started communicating with other children, parents as well
as teachers noticed that he became calmer, hysterias occur more
rarely, instead he argues with words to show his unwillingness to
do something, but calms down very soon, vocalizations stopped, his
eye contact improved, muscle strength increased, he can climb the
stairs by himself, started trying new types of food, and appetite
improved.
Example 10--5-Year-Old Male "M. K."
[0164] M. K. 5 year old boy had mild language impairment,
echolalia, severe problems with social communication and
understanding, had signs of compulsive-obsessive behavior and mild
restricted and repetitive behavior, was diagnosed with ASD at age
3. Parents' complaints were "scanty speech, echolalia, repetition
of question before answering, ignoring other people, unrelated
answers, impaired eye contact, obsessive phrases, sequencing,
ritualism and hyperactivity."
[0165] The parents did not answer the questions regarding
pregnancy, parturition and first months of the child's life.
[0166] Prior to the subject therapy the following drugs and therapy
were applied: Omega-3; Tomatis therapy, psychologist, speech
therapist and defectologist, exercise therapy, hippotherapy;
homeopathy, BAC, acupuncture. As the result concentration and
understanding has improved, solved the problem of nocturnal
enuresis, improved general physical skills, slightly improved
speech.
[0167] Blood work: Erythrocytosis, thrombocytosis, neutrophilia,
eosinophilia, lymphocytosis, increased hematocrit, and ESD,
detected IgG to CMV, HSV, EBV (EBNA), rubella virus and IgM to
Giardia were over reference ranges, reduced T-helpers/T-suppressors
ratio.
[0168] In 45 days the treatment was initiated: thrombocytes,
neutrophils, eosonophils and ESD became within reference ranges,
hematocrit and lymphocytes count did not change, hemoglobin and RDW
increased over reference ranges, IgG to CMV increased slightly, IgG
to HSV did not change, IgG to EBV reduced significantly, IgM to
Giardia--within reference range, IgG test to rubella virus was not
completed. CD4/CD8 ratio reduced, B-lymphocytes and T-helper counts
reduced below the reference range.
[0169] Additionally, parents reported that: vocabulary increased,
he started to use speech more often, remembered the words that he
had learned before the regression, builds phrases. He now expresses
a willingness to interact with other children, starts to understand
how to communicate with peers, socialization has improved.
Nonverbal communication has also improved, in his responses
understanding and adequacy appeared. Also, parents reported that
his memory has improved--he remembers some situations, tells how
his day was.
Example 11--5-Year-Old Male "A. B."
[0170] A. B. 5 year old boy had significantly reduced speaking
ability, severe social communication problems, mild repetitive and
restricted behavior, was diagnosed with ASD at age of 3. Parents'
complaints were "usage of only few learned words, inability to
communicate with other children, impaired eye contact, problems
with understanding, absence of dialogues, repetitive finger
movements, hyperactivity, anxiety and frequent respiratory
infections."
[0171] According to parents, pregnancy and parturition were not
complicated, but the child was born with hypoxia. From the first
days after birth, the child was unusually calm, did not need
attention, did not feel pain.
[0172] Prior to the subject treatment, the child received the
following therapies: speech therapy, defectologist, psychologist;
microcurrent reflexotherapy, osteopathy, massage, acupuncture. As
the result, only the physical condition of the child has
improved.
[0173] Blood work: Decreased MCH, increased RDW and trombocrit,
detected IgG to EBV and rubella virus are over reference range,
decreased T-lymphocytes, T-helper, T-suppressor, B-lymphocyte
counts.
[0174] In 80 days the treatment was initiated: red blood cell count
did not change, but also thrombocytosis appeared, IgG to rubella
virus and EBV decreased, T-lymphocytes are within reference range,
other immune cells count did not change.
[0175] Additionally, the parents reported that the child started
actively trying to repeat some new words and to talk more, eye
contact improved, motor skills improved. During the treatment, the
child had respiratory infection, and the process of recovery was
easier and quicker.
Example 12--3-Year-Old Male "K. S."
[0176] K. S., a 3 year old boy with significantly reduced speaking
ability, moderate restricted and repetitive behavior, severe
difficulties with social communications, and anxiety, was diagnosed
with speech development delay with autistic behavior in age of 2.6.
Parents' complaints were "lack of speech, periodical repetitive
behavior, biting his fingers, frequent hysterias, impaired eye
contact, and inability to communicate."
[0177] According to parents, the child was born with hypoxia, in
the early childhood he was restless, often cried, did not look into
eyes, and had sleep deprivation.
[0178] Prior to our treatment, the child received the following
drugs and therapies: Valtrex, Gammalon; ABA therapy, Montessori
method, massage, speech therapy; microcurrent reflexotherapy.
According to parents, the most effective was Valtrex. After this he
became more communicative, attempts to speak appeared, became
calmer, eye contact has improved.
[0179] Blood work: Lymphocytosis, erythrocytosis, eosinophilia,
basophilia, increased hematocrit, detected IgG to HSV, EBV (VCA),
Mycoplasma spp. and H. Pylori were above reference ranges, NK cells
and T-Iymphocytes counts as well as T-helper/T-suppressor ratio
were decreased.
[0180] In 80 days the treatment was initiated: eosinophils and
basophils counts decreased, erythrocytes count and hematocrit did
not changes, at the same time the monocytes count increased above
reference ranges, IgG to H. Pylori decreased to a reference range,
IgG to mycoplasma, HSV and EBV did not change, immune cells count
did not change.
[0181] Additionally, parents reported that the child started
speaking, some new words appeared, he built 3 new sentences for the
first time, started to understand addressed speech, eye contact has
significantly improved, became more interested in peers and more
communicative, defends himself if someone pushes him, became more
self-dependent, anxiety disappeared, sensitivity became
normal--stopped biting his fingers.
Example 13--3-Year-Old Female "A. R."
[0182] A. R., a 3 year old girl had significantly reduced speaking
ability, difficulties with understanding of addressed speech, mild
restricted and repetitive behavior, anxiety and hyperactivity, was
diagnosed with "speech development with autistic behavior" at age
of 3. Parents' complaints were: "few words in the vocabulary,
inability to speak clearly, misunderstanding of addressed speech
and as a result impaired social communication skills, restricted
behavior, difficulties in expressing emotions, anxiety,
claustrophobia and hyperactivity."
[0183] According to the parents, the pregnancy was complicated:
respiratory infection in the second trimester, low hemoglobin
during pregnancy. Parturition was with long anhydramnious period.
The child was born with hypoxia. During the first months of life
the child was restless, cried a lot, problems with sleep were
present, and frequent respiratory infections.
[0184] Prior to our treatment, the child received the following
types of treatment: Cortexin, Pancalcin, Efalex, Vitamins B;
microcurrent reflexotherapy. None of these treatments gave positive
results.
[0185] Blood work: Neutropenia, increased RDW, detected IgG to
rubella virus, EBV and CMV are above reference ranges,
B-lymphocyte, T-suppressor counts are increased, NK cells count is
decreased.
[0186] In 30 days the treatment was initiated: neutrophils became
of a reference range, RDW did not change, but erythrocytes count
and hematocrit slightly increased above reference ranges, IgG to
all detected viruses slightly increased. Immune cells analysis was
not conducted.
[0187] Additionally, the parents reported the following changes:
the understanding of speech improved, the child became more
self-dependent, claustrophobia stopped.
Example 14--8-Year-Old Male "A. A."
[0188] A. A., an 8 year old boy had mild language impairment, mild
social communication problems and moderate restricted and
repetitive behavior, sleep deprivation, anxiety and hyperactivity.
He was diagnosed with ASD at age 3.5. Parents' complaints were
"short phrases with wrong construction, repetitive behavior and
restriction on some objects, misunderstanding of how to communicate
with other people, inadequate reaction when interest towards him is
demonstrated, signs of obsessive-compulsive syndrome,
hyperactivity, anxiety, sleep deprivation and selectivity of
food."
[0189] Parents did not provide the information on pregnancy,
parturition and first months of the child's life.
[0190] Prior to the subject treatment the child received the
following therapies: ABA therapy, exercise therapy, massage, speech
therapy, psychological therapy, manual therapy, and Tomatis. These
therapies as a complex, slightly improved social communication
skills, language skills and improved behavior.
[0191] Blood work. Leukopenia, eosinophilia, detected IgG to
rubella virus, EBV and CMV were above reference ranges, reduced
T-helper count and reduced T-helper/T-suppressor ratio.
[0192] In 45 days the treatment was initiated: leukopenia did not
change, eosinophils count--within reference ranges, monocytes count
increased above reference range, IgG to EBV reduced by 13 times,
IgG to rubella did not change, IgG to CMV increased slightly.
Immune analysis was not conducted.
[0193] Additionally, the parents reported the following changes:
the speech became more complicated--new phrases, sentences, which
became more grammatically correct, pronunciation became more clear,
repetitive behavior notably decreased, eye contact improved--often
looks and for long, became more sociable, plays more often with
other children and started to initiate games by himself, sleep is
better--falls asleep much faster (30 min instead of 2 h), started
trying new types of food.
Example 15--7-Year-Old Male "D. M."
[0194] D. M., a 7 year old boy had no speech, severe repetitive and
restricted behavior, difficulties regarding communication due to
absence of speech and misunderstanding of the addressed speech. He
was diagnosed with ASD at age of 4. Parents' complaints were
"absence of speech, constant stereotypical behavior,
misunderstanding how to communicate with other people, problems
with nonverbal communication, selectivity of food and
hypersensitivity."
[0195] According to parents, the pregnancy was complicated:
respiratory infection in the second trimester, the child was born
with asphyxia, the child was unusually quiet from the first days of
life, fell asleep by himself, did not need attention, had frequent
respiratory infections.
[0196] Prior to our treatment the child received the following
drugs and therapies: Pantogam, Cortexin, Tenoten, Mexidol, Depakin,
Gliatilin, Sturegon; massage, microcurrent reflexotherapy. After
these treatments the parents did not notice significant results.
After some of the drugs the child became more hyperactive.
[0197] Blood work: Erythrocytosis, neutropenia, basophilia,
lymphocytosis, increased MCV, detected IgG to CMV, EBV, HSV and
rubella virus were above reference ranges. All immune cells--within
reference ranges.
[0198] In 120 days the treatment was initiated: erythrocytes count
became within reference range, all other parameters did not change,
IgG to rubella virus and CMV increased, IgG to EBV and HSV
decreased, T-helper/T-suppressor ration decreased below reference
range.
[0199] Additionally, the parents reported that during the treatment
the child for the first time said phrase "I will," he became
attached to his favorite toy, he takes it everywhere--before he did
not have such attachment.
Example 16--5-Year-Old Male "K. T."
[0200] K. T., a 5 year old boy had moderate language impairment,
moderate social communication problems and restricted and
repetitive behavior, hypersensitivity and hyperactivity. The child
was diagnosed with psycho-speech development delay at age of 2.
Parents' complaints were "undeveloped speech, inability to build
phrases, restriction on some objects, misunderstanding of how to
communicate with others, hearing hypersensitivity, severe
hyperactivity."
[0201] According to the parents, the pregnancy was complicated: CMV
infection during pregnancy, the child was born with asphyxia due to
umbilical cord vein. After birth the child was unusually quiet,
could lay by himself for a long time.
[0202] Prior to the subject treatment the child received the
following therapies: gluten-free, casein-free diet, microcurrent
reflexotherapy. After these, the parents did not notice any
results.
[0203] Blood work: Increased hematocrit and MCHC, decreased PTW,
neutropenia and basophilia, detected IgG to CMV, EBV and rubella
virus above reference ranges, EBV, CMV and HSV were detected using
PCR method, increased NK cells count, decreased B-lymphocytes
count, reduced T-helpers/T-suppressors ratio.
[0204] In 80 days the treatment was initiated: PTW, neutrophils
count, basophils count--within reference ranges, hematocrit, MCHC
did not change, erythrocytosis, thrombocytosis, decreased MPV. IgG
to EBV and CMV decreased, IgG to rubella increased. Immune
cells--all within reference ranges, apart from reduced
T-helpers/T-suppressors ratio.
[0205] Additionally, the parents reported: the speech became more
clear, new complex sentences appeared, vocabulary increased,
started asking questions, became more sociable, tries to initiate
games, more attentive to other children, understanding of addressed
speech improved, eye contact became more conscious, hearing
sensitivity reduced, became calmer, new skills appeared: drawing,
singing.
Example 17--3-Year-Old Male "K. D."
[0206] K. D. 3 y.o. boy had no speech, severe difficulties with
social communication, severe repetitive and restricted behavior.
The child was diagnosed with child autism at age of 3. The parents'
complaints were "absence of speech, frequent repetitive and
restricted behavior, impaired eye contact, ignoring other people,
lack of interest to other children, inability to express
emotions".
[0207] According to the parents, the pregnancy was complicated,
there was a risk of miscarriage in the first semester of pregnancy,
the child was born with hypoxia. During the first year of life the
child was very quiet, rarely cried.
[0208] Prior to our treatment the child received microcurrent
reflexotherapy method. After this the regression of autistic
symptoms occurred.
[0209] Blood work. Erythrocytosis, neutropenia, lymphocytosis,
decreased MCH, detected IgG to CMV was above reference range. All
immune cells were within reference ranges.
[0210] In 45 days the treatment was initiated: erythrocytes,
neutrophils, lymphocytes count--within reference ranges, decreased
MCH, thrombocytosis, IgG to CMV decreased by 77 times. Immune cells
analysis was not conducted.
[0211] Additionally, parents reported that vocabulary increased,
started to understand addressed speech, became calmer, the sense of
empathy appeared.
Example 18--3-Year-Old Male "E. A."
[0212] E. A. 3 y.o. boy had no speech, severe problems with social
communication and mild repetitive and restricted behavior. He was
diagnosed with ASD at age of 2. Parents' complaints were "absence
of speech, only separate sounds, misunderstanding of how to play
and communicate with other children, reduced spectrum of emotions,
stereotypical games, preference to be separate from peers, impaired
eye contact, reduced sensitivity, GI and respiratory tracts
frequent disorders".
[0213] According to parents, the pregnancy was complicated:
respiratory infection in the second trimester of pregnancy. After
birth the child was unusually quiet, rarely pronounced any sounds,
and even if cried did it very quietly.
[0214] Prior to our treatment the child received Cerebrolysin,
Ceraxon, Pantocalcin, Pantogam, Tenoten, Encephabol, Noofen,
Gliatylin; speech therapy, osteopathy; BAC, transcranial
polarization. These treatments resulted in appearance of new
sounds, improved eye contact, improved behavior and physical
skills.
[0215] Blood work. Erythrocytosis, neutropenia, lymphocytosis,
eosinophilia, increased MCH, MCV, and RDW. Detected IgG to rubella
virus, CMV, EBV, HSV, Mycoplasma are above reference ranges.
Decreased B-lymphocytes count.
[0216] In 45 days the treatment was initiated: blood cells count
did not change, apart from eosinophils count, that became within
reference range, IgG to HSV and mycoplasma--within reference
ranges, IgG to EBV, CMV and rubella did not change significantly,
all immune cells--within reference ranges.
[0217] Additionally, parents reported that the child became more
communicative, started to use gestures for communication,
constructs dialogues in that way, learned new sounds, pronounces
them with intonation, tries to say some words, started playing with
other children, imitates others, reacts to and understands
addressed speech, improved eye contact, does not focus that much on
objects, disappoints when parents go to work, became more
self-dependent, helps mother, more attached to family members,
memorization improved, sleeps better.
Example 19--2-Year-Old Male "I. C."
[0218] I. C. 2 y.o. boy had no speech, moderate problems with
social communication, mild repetitive and restricted behavior,
severe hyperactivity, was diagnosed with psycho-speech development
delay at age of 2. Parents' complaints were "no speech, no
understanding of addressed speech, misunderstanding of how to
communicate with others, ignoring others, pronounced hyperactivity,
gastrointestinal tract disorders, allergy".
[0219] Parents did not provide the information of pregnancy,
parturition and first year of the child's life.
[0220] Prior to our treatment, the child received the following
therapies: massage, gluten-free, lactose-free diet, speech therapy,
correctional therapy. After these therapies parents did not notice
any significance differences.
[0221] Blood work. Neutropenia, lymphocytosis. EBV was found in
saliva using PCR method. Decreased t-helper, T-suppressor counts
and reduced T-helpers/T-suppressors ratio.
[0222] In 45 days the treatment was initiated: neutrophils and
lymphocytes counts--within reference ranges, monocytosis. T-helpers
count and T-helpers/T-suppressors ratio--within reference ranges.
T-suppressors and B-lymphocytes counts decreased.
[0223] Additionally, parents reported that the child started to
repeat more words after parents, behavior improved, understanding
of addressed speech improved, if people around start laughing, he
laughs too.
Example 20--11-Year-Old Male "S. Z."
[0224] S. Z. 11 y.o. boy had moderate language impairment, severe
restricted and repetitive behavior, moderate social communication
problems, hypersensitivity, anxiety and hyperactivity. Was
diagnosed with regressive autism at age of 3. Parents' complaints
were "reduced speaking ability, short sentences, speech defects,
unwillingness to communicate, frequent repetitive behavior,
fixations, anxiety when stays alone at home, lack of interest to
peers, unrelated answers, hearing hypersensitivity, and reduced
sensitivity to pain, hyperactivity".
[0225] According to parents, the parturition was immature, the
child was born with weight deficit. At first months of life there
were delays in physical skills, was unusually quiet.
[0226] Prior to our treatment the child received the following
treatment: Nistatin, Memantine, dolphin therapy, Tomatis, speech
therapy, occupational therapy, game therapy, gluten-free,
lactose-free, soy-free diet. According to parents, none of these
methods showed significant results.
[0227] Blood work. Erythrocytosis, basophilia, increased
hemoglobin, hematocrit, and MCV, detected IgG to EBV, CMV, rubella
virus and H. pylori are above reference ranges, reduced
T-helpers/T-suppressors ratio.
[0228] In 45 days the treatment was initiated: blood parameters did
not change, apart from basophils which became of reference range
and appeared neutropenia and eosinophilia. IgG to H. pylori--within
reference range, IgG to EBV, rubella virus and CMV decreased.
Reduced T-helpers/T-suppressors ratio.
[0229] Additionally, the parents reported that the vocabulary
increased, the speech became more clear, the child started speaking
to himself, eye contact improved, stopped biting his nails.
Example 21--Summary of Results
TABLE-US-00004 [0230] TABLE 4 The summary of the positive results
obtained after treatment in each category. Problem Result of the
treatment Social Understanding of addressed speech appeared,
communication a child became more communicative, improved problems
eye contact and nonverbal communication, empathy appeared,
attachment and tenderness to family members, started playing with
peers, began to joke, reacting to other people, improved
socialization, usage of gestures for communication Language
Increased vocabulary, ability to build sentences, impairment
clearer speech, more conscious and constructive speech,
grammatically correct speech, participation in dialogues, verbal
expression, repetition of words after parents, more complex
sentences Repetitive and Reduced repetitive movements, echolalia,
less restricted excessive focusing behavior Neurological A child
became calmer, less anxious, less and hyperactive, hyper- or
hyposensitivity reduced, psychological more initiation, less
aggressiveness, improved problems sleep, studying process improved,
GI and Less frequent respiratory and GI infections, more
respiratory frequent stool, loss of excessive tracts disorders
weight, trying new types of food, less constipation, improved
appetite, Other skills Improved writing skills, drawing, singing,
physical skills, motor function, logical thinking, memorization,
more self-dependence,
TABLE-US-00005 TABLE 5 Description of the positive results in
social communication problems after treatment. # of children # of
with Description children changes of social having in social # of
children-- communication the commu- description of problems
problems nication changes Inability to initiate 20 19 12--improved
and to participate understanding of in communication, addressed
speech Ignoring other 12--a child became people, more communicative
Lack of interest 9--improved eye to peers, contact Misunderstanding
3--improved nonverbal of nonverbal communication communication,
3--empathy appeared Impaired eye contact, 4--attachment and
Inability to express tenderness to emotions, family members
Preference to stay 7--started playing with separate from others,
peers Misunderstanding of 2--began to joke and the addressed speech
to understand jokes Unrelated and 3--started reacting to illogical
statements other people 1--usage of gestures for communication
TABLE-US-00006 TABLE 6 Description of the positive results in
descriptive and repetitive behavior after treatment. # of children
# of with Description of children changes in restricted and having
restricted and # of children-- repetitive the repetitive
description of behavior problems behavior changes Repetitive motor
20 8 3--reduced repetitive movements, movements Stereotypical
1--reduced echolalia movements, 4--less excessive Echolalia,
focusing Excessive focusing and fixation on some objects, Obsessive
behavior, Rituality, Vocalization, Sequencing
TABLE-US-00007 TABLE 7 Description of the positive results in
language impairment after treatment. # of children # of with
Description of children changes language having in # of children--
impairments the language description according to DSM-5 problems
skills of changes Nonverbality, 20 17 12--increased Significantly
vocabulary reduced vocabulary, 7--ability to build Inability to
build sentences sentences, 4--clearer speech Scanty speech, 2--more
conscious and Problems with constructive speech pronunciation,
4--participation in Grammatically dialogues incorrect speech,
5--verbal expression Rare usage of speech, 3--repetition of words
No participation after parents in dialogues, Speech defects
TABLE-US-00008 TABLE 8 Description of the positive results in
neurological and psychological problems after treatment. # of
children Description of # of with changes in neurological children
neurological and having and # of children-- psychological the
psychological description of problems problems problems changes
Sleep disorders, 14 12 6--reduced Anxiety, hyperactivity
Hyperactivity, 3--reduced anxiety Passiveness 2--reduced hyper-
Hypersensitivity, or hyposensitivity Hyposensitivity, 2--improved
sleep Aggressiveness, 2--improved Self- studying process
aggressiveness,
TABLE-US-00009 TABLE 9 Description of the positive results in GI
and respiratory after treatment. # of children with changes
Description # of in GI and of GI and children respiratory # of
children-- respiratory having the tracts description of tracts
disorders problems disorders changes Selectivity 12 9 3--less
frequent of food, respiratory Constipations, and GI infections
Frequent 1--loss of excessive respiratory weight infections,
4--trying new types GI disorders, of food Allergy 2--less frequent
constipations
TABLE-US-00010 TABLE 10 Description of the positive results in
other categories after treatment. # of children with changes in
other skills Description of changes 12 1--improved writing skills
3--increased imagination 3--improved physical skills and motor
function 1--improved logical thinking 3--improved memorization
6--more self-dependence
* * * * *