U.S. patent application number 15/251725 was filed with the patent office on 2016-12-22 for bacteriotherapy for clostridium difficile colitis.
The applicant listed for this patent is REBIOTIX, INC.. Invention is credited to EDWIN J. HLAVKA.
Application Number | 20160367607 15/251725 |
Document ID | / |
Family ID | 44319684 |
Filed Date | 2016-12-22 |
United States Patent
Application |
20160367607 |
Kind Code |
A1 |
HLAVKA; EDWIN J. |
December 22, 2016 |
BACTERIOTHERAPY FOR CLOSTRIDIUM DIFFICILE COLITIS
Abstract
This document discusses, among other things, receiving a
plurality of donor fecal samples from a plurality of donors and
storing and indexing each respective donor fecal samples using at
least one characteristic of the respective donor fecal sample. In
an example, the donor fecal sample can be screened and processed
for subsequent use in fecal bacteriotherapy to displace pathogenic
or undesired organisms in the digestive track of a patient with
healthy or desirable gut microbiota.
Inventors: |
HLAVKA; EDWIN J.;
(Minneapolis, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
REBIOTIX, INC. |
Roseville |
MN |
US |
|
|
Family ID: |
44319684 |
Appl. No.: |
15/251725 |
Filed: |
August 30, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14093913 |
Dec 2, 2013 |
9463208 |
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15251725 |
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13576573 |
Oct 17, 2012 |
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PCT/US2011/000184 |
Feb 1, 2011 |
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14093913 |
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61337283 |
Feb 1, 2010 |
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61351184 |
Jun 3, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
C12N 1/20 20130101; C12N
1/04 20130101; G01N 2333/33 20130101; A61K 35/74 20130101; G01N
2800/52 20130101; A61P 31/04 20180101; A61P 1/00 20180101; G01N
33/56911 20130101; A61K 9/20 20130101; A61P 1/12 20180101; A61K
35/741 20130101 |
International
Class: |
A61K 35/741 20060101
A61K035/741; C12N 1/04 20060101 C12N001/04; A61K 9/20 20060101
A61K009/20 |
Claims
1. A method for treating a digestive disorder, the method
comprising: preparing a first bacteriotherapy composition by
obtaining a first donor fecal sample from a first donor,
homogenizing the first donor fecal sample with a first
cryoprotectant, and then filtering; preparing a second
bacteriotherapy composition by obtaining a second donor fecal
sample from a second donor, homogenizing the second donor fecal
sample with a second cryoprotectant, and then filtering; storing
the first bacteriotherapy composition and the second
bacteriotherapy composition in a temperature controlled storage
bank; wherein the first bacteriotherapy composition includes a
first dietary characteristic of the first donor; wherein the second
bacteriotherapy composition includes a second dietary
characteristic of the second donor different from the first dietary
characteristic of the first donor; wherein the first dietary
characteristic and the second dietary characteristic are a human
donor geographic consumption region, a human donor diet, a human
donor religion, or combinations thereof and are configured to be
matched to a patient having a digestive disorder such that a donor
gut microbiota of the respective donor and a patient gut microbiota
of the patient are similar; and administering either the first
bacteriotherapy composition or the second bacteriotherapy
composition to the patient by oral, naso-gastric, antegrade
gastrointestinal, retrograde gastrointestinal, endoscopic, or
enemic administration.
2. The method of claim 1, wherein the first cryoprotectant, the
second cryoprotectant, or both includes a glycol.
3. The method of claim 1, wherein the first cryoprotectant, the
second cryoprotectant, or both includes glycerol.
4. The method of claim 1, wherein the first cryoprotectant and the
second cryoprotectant are the same.
5. The method of claim 1, wherein prior to obtaining the first
donor fecal sample, the health of the first donor is pre-screened
to exclude an unhealthy donor.
6. The method of claim 5, wherein pre-screening the health of the
first donor comprises testing blood and fecal samples from the
first donor for at least one of a parasite, a pathogen, a disease,
or an unhealthy condition of the first donor.
7. The method of claim 1, further comprising freezing the first and
second bacteriotherapy compositions, storing the first and second
bacteriotherapy compositions in the temperature controlled storage
bank, and thawing either the first bacteriotherapy composition or
the second bacteriotherapy composition prior to administration to
the patient.
8. The method of claim 1, wherein the first and second
bacteriotherapy compositions contains a viable population of
microbiota.
9. The method of claim 1, further comprising forming the first
bacteriotherapy composition into a first pill and forming the
second bacteriotherapy composition into a second pill and wherein
administering the either the first bacteriotherapy composition or
the second bacteriotherapy composition includes administering
either the first pill or the second pill.
10. A method for forming a fecal bank, the method comprising:
preparing a first composition by obtaining a first donor fecal
sample from a first donor, homogenizing the first donor fecal
sample with a first cryoprotectant, and then filtering; preparing a
second composition by obtaining a second donor fecal sample from a
second donor, homogenizing the second donor fecal sample with a
second cryoprotectant, and then filtering; storing the first
composition and the second composition in a temperature controlled
storage bank; wherein the first composition includes a first
dietary characteristic of the first donor; wherein the second
composition includes a second dietary characteristic of the second
donor different from the first dietary characteristic of the first
donor; and wherein the first dietary characteristic and the second
dietary characteristic are a human donor geographic consumption
region, a human donor diet, a human donor religion, or combinations
thereof and are configured to be matched to a patient having a
digestive disorder such that a donor gut microbiota of the
respective donor and a patient gut microbiota of the patient are
similar.
11. The method of claim 10, wherein the first cryoprotectant, the
second cryoprotectant, or both includes a glycol.
12. The method of claim 10, wherein the first cryoprotectant, the
second cryoprotectant, or both includes glycerol.
13. The method of claim 10, wherein the first cryoprotectant and
the second cryoprotectant are the same.
14. The method of claim 10, wherein prior to obtaining the first
donor fecal sample, the health of the first donor is pre-screened
to exclude an unhealthy donor.
15. The method of claim 14, wherein pre-screening the health of the
first donor comprises testing blood and fecal samples from the
first donor for at least one of a parasite, a pathogen, a disease,
or an unhealthy condition of the first donor.
16. The method of claim 10, further comprising freezing the first
and second compositions, storing the first and second compositions
in the temperature controlled storage bank, and thawing either the
first or the second composition prior to administration to the
patient.
17. The method of claim 10, wherein the first and second
compositions contains a viable population of microbiota.
18. The method of claim 10, further comprising administering either
the first composition or the second composition to the patient by
oral, naso-gastric, antegrade gastrointestinal, retrograde
gastrointestinal, endoscopic, or enemic administration.
19. The method of claim 18, further comprising forming the first
composition into a first pill and forming the second composition
into a second pill and wherein administering the either the first
composition or the second composition includes administering either
the first pill or the second pill.
20. A method for forming a fecal bank, the method comprising:
preparing a first composition by obtaining a first donor fecal
sample from a first donor, homogenizing the first donor fecal
sample with a first cryoprotectant, and then filtering; preparing a
second composition by obtaining a second donor fecal sample from a
second donor, homogenizing the second donor fecal sample with a
second cryoprotectant, and then filtering; storing the first
composition and the second composition in a temperature controlled
storage bank; wherein the first composition includes a first
dietary characteristic of the first donor; wherein the second
composition includes a second dietary characteristic of the second
donor different from the first dietary characteristic of the first
donor; and wherein the first dietary characteristic and the second
dietary characteristic are configured to be matched to a patient
having a digestive disorder such that a donor gut microbiota of the
respective donor and a patient gut microbiota of the patient are
similar.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 14/093,913, filed Dec. 2, 2013, which is a continuation of U.S.
application Ser. No. 13/576,573, filed on Oct. 17, 2012, which is a
371 national stage of PCT/US2011/000184, filed on Feb. 1, 2011,
which claims the benefit of priority under 35 U.S.C. .sctn.119 to
U.S. Application No. 61/337,283, filed on Feb. 1, 2010, and which
also claims priority to U.S. Application No. 61/351,184, filed on
Jun. 3, 2010, all of which applications are herein incorporated by
reference.
BACKGROUND
[0002] Between 300 and 1000 different species of bacteria reside in
a healthy gastrointestinal (GI) tract. Clostridia are anaerobic,
spore-forming bacteria. Certain species of clostridium are
pathogens, producing toxins that can be harmful to humans.
Clostridium difficile ("C. diff") is one species of clostridium
that, if overpopulated in the GI tract, can release toxins that can
cause a number of symptoms, including bloating, constipation,
diarrhea, inflammation, abdominal pain, among others that, in
certain cases, can lead to death.
[0003] When stressed, clostridium difficile create spores that can
tolerate extreme conditions many active bacteria cannot. Generally,
clostridia do not compete well in a healthy GI tract. However,
antibiotics can disrupt the normal intestinal flora, leading to an
overgrowth of clostridium difficile. In certain examples, the
clostridium difficile spores can be resistant to various
antibiotics. Thus, as the normal intestinal flora is cleared, the
clostridium difficile spores remain, leading to a large population
of clostridium difficile.
OVERVIEW
[0004] This document discusses, among other things, receiving a
plurality of donor fecal samples from a plurality of donors and
storing and indexing each respective donor fecal samples using at
least one characteristic of the respective donor fecal sample. In
an example, the donor fecal sample can be screened and processed
for subsequent use in fecal bacteriotherapy to displace pathogenic
or undesired organisms in the digestive track of a patient with
healthy or desirable gut micriobiota.
[0005] This overview is intended to provide an overview of subject
matter of the present patent application. It is not intended to
provide an exclusive or exhaustive explanation of the invention.
The detailed description is included to provide further information
about the present patent application.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] In the drawings, which are not necessarily drawn to scale,
like numerals may describe similar components in different views.
Like numerals having different letter suffixes may represent
different instances of similar components. The drawings illustrate
generally, by way of example, but not by way of limitation, various
embodiments discussed in the present document.
[0007] FIG. 1 illustrates generally an example of a Treatment Model
including a 5 day fecal bacteriotherapy treatment cycle.
[0008] FIG. 2 illustrates generally an example of a bacteriotherapy
bank configured to store one or more processed and screened donor
fecal samples.
[0009] FIG. 3 illustrates generally an example of a method of
receiving and storing donor fecal samples.
[0010] FIG. 4 illustrates generally an example of a method of
receiving, storing, and indexing donor fecal samples.
DETAILED DESCRIPTION
[0011] Each individual has a personalized gut microbiota including
an estimated 500 to 5000 or more species of bacteria, fungi,
archaea and other microorganisms, up to 100 trillion individual
organisms, that reside in the digestive tract, providing a host of
useful symbiotic functions, including aiding in digestion,
providing nutrition for the colon, producing vitamins, stimulating
the immune system, assisting in defense against exogenous bacteria,
modulating energy metabolism, etc. However, an improperly balanced
or functioning gut microbiota may play a role in certain diseases
or afflictions, such as pseudomembranous colitis, clostridium
difficile colitis, antibiotic-associated diarrhea (AAD), ulcerative
colitis (UC), pouchitis, irritable bowel syndrome (IBS), obesity,
among others.
[0012] Accordingly, the present inventor has recognized, among
other things, systems and methods for providing bacteriotherapy to
treat afflictions associated with the gut microbiota, including
clostridium difficile colitis, by displacing pathogenic organisms
in the digestive track of a patient with healthy bacterial flora,
or bacterial flora intended to benefit a specific individual with
an affliction associated with the gut microbiota. In an example,
the systems and methods described herein can provide a convenient,
hygienic mechanism, capable of meshing with existing capabilities
and routines of existing clinics and hospitals, for providing
bacteriotherapy to a patient. In certain examples, similar
treatment can be effective for patients with other diseases, such
as IBS, crones, ulcer, or other gastrointestinal or digestive tract
related disease. In other examples, bacteriotherapy can be used to
aid in weight loss, displacing ineffective flora in the gut with a
more effective microbiota.
[0013] For example, estimates of clostridium difficile
overpopulation incidence vary from 1.5 to 2.7 million occurrences
in the United States per year, and are growing. In one estimate,
hospital discharges with clostridium difficile doubled from 2001 to
2005, with an estimated 5% to 25% compound annual growth rate.
Current estimates indicate that patients affected by clostridium
difficile overpopulation experience increased hospital stays from 3
to 36 days, with nearly 20% of affected patients being readmitted
within 180 days, each more likely to be discharged to long-term
care facilities than patients not affected. The financial impact of
clostridium difficile is estimated at $1 to $3 billion annually.
Moreover, an estimated 300 patient deaths per day are attributable
to clostridium difficile overpopulation, a mortality rate of 1 to
7.7%, and increasing.
[0014] Traditional treatment for clostridium difficile typically
includes application antiobotics. Metronidazole ("Flagyl.RTM.") is
the antibiotic of choice due to low price and high efficacy.
However, for recurring cases (up to 20% of total cases, for
example, resistant to metronidazole), pregnant patients, or
patients younger than 10 years of age, vancomycin ("Vancocin.RTM.")
is typically used. However, vancomycin, although typically having
fewer side effects than metronidazole, has a much higher cost and
may lead to resistance of existing clostridium difficile to further
antiobiotics.
[0015] At first occurrence, antibiotic treatment for clostridium
difficile can be acutely effective to treat diarrhea within 2 to 4
days at a rate approximately at or above 90%. However, clostridium
difficile typically recurs after the first occurrence (e.g.,
several days to 12 weeks after cessation of antibiotics) at an
estimated 20% rate (e.g., 15%-30%). However, for each recurrence
following the first recurrence, the rate increases greatly, to an
estimated 40% rate following the second recurrence, and to greater
than an estimated 60% rate or greater thereafter. It is estimated
that approximately 5% of patients have 6 or more recurrences.
[0016] Treatment for clostridium difficile typically varies after
each occurrence. For example, for first mild to moderate
recurrence, metronidazole can be administered orally (e.g., at a
dose of 500 mg, three times daily ("TID") for 10 to 14 days). For a
second recurrence, vancomycin can be administered orally in tapered
or pulsed doses (e.g., at a dose of 125 mg, four times daily
("QID") for 14 days; at a dose of 125 mg, twice daily ("BID") for 7
days; at a dose of 125 mg, once daily ("QD") for 7 days; at a dose
of 125 mg, once every 2 days for 8 days (four doses); at a dose of
125 mg, once every 3 days for 15 days (five doses), etc.). For a
third recurrence, vancomycin can be applied at greater doses (e.g.,
at a dose of 125 mg, four times daily ("QID") for 14 days),
combined with any of the other options for recurrent infection,
such as intravenous immunoglobulin (e.g., at a dose of 400 mg per
kg body weight, once every three weeks, for a total of two or three
doses depending on effect), or rifamycin following the vancomycin
doses (e.g., the rifamycin at a dose of 400 mg, twice daily ("BID")
for 14 days), etc.
[0017] In an example, bacteriotherapy to treat clostridium
difficile or one or more other diseases or afflictions of the
digestive tract can be provided using a combination of antibiotics
and re-population of a healthy or desired bacterial flora. In
certain examples, the re-population of bacterial flora can include
fecal bacteriotherapy, or fecal transplant.
[0018] The process of fecal bacteriotherapy can include introducing
a fecal sample of a healthy donor, or a donor having one or more
desired characteristics, into a gastrointestinal tract of a patient
to repopulate a healthy or desirable gut microbiota. In certain
examples, prior to introduction of the fecal sample, the patient's
intestinal flora can be disrupted using antibiotics, such that the
healthy or desirable gut microbiota, once introduced into the
patient, can easily populate the gastrointestinal tract.
[0019] In an example, a kit of parts can be created to aid in fecal
transplant. In an example, a donation kit can be shipped to a
clinician. The donation kit can include equipment for blood and
fecal samples from the patient or, in certain examples, a healthy
donor. Because much of the patient's gut micriobiota is anaerobic,
many organisms can die with exposure to air. In an example, the
donation kit can include materials to ship the blood and fecal
samples without harming the samples (e.g., quick freeze, dry ice,
etc.).
[0020] Once shipped to a facility (e.g., one location, regional
locations, many locations, etc.), the samples can be tested, and
clostridium difficile or the presence or absence of one or more
other diseases or conditions can be confirmed. In other examples, a
healthy fecal sample can be tested and prepared for use as a
treatment.
[0021] In an example, once the patient's samples are tested to
verify the disease or condition, or the donor's samples are tested
to verify health or other compatibility (e.g., the existence of one
or more desired condition, etc.), a treatment can be prepared
(e.g., using the healthy donor fecal sample, at least a portion of
one or more healthy stored fecal samples, such as material from a
fecal bank, etc.) and shipped back to the clinician for delivery to
and treatment of the patient. In certain examples, the treatment is
preserved (e.g., frozen, etc.) during shipping. The kit can include
the processed fecal sample or treatment in a sterile container,
such as a nasogastric (NG) tube, a vial (e.g., for use with a
retention enema), a gastro-resistant capsule (e.g., acid-bio
resistant to reach the intestinal tract, having a sterile outside),
etc. In an example, once received, the clinician can store the
contents in a manner to preserve the micriobiota until ready to be
inserted into the patient.
[0022] FIG. 1 illustrates generally an example of a Treatment Model
100 including a 5 day fecal bacteriotherapy treatment cycle. At
105, day 0, recurrence of a condition, such as clostridium
difficile colitis or one or more other afflictions associated with
the gut microbiota, is detected in a patient. In an example, the
condition can be detected using the presentation of one or more
symptoms associated with the condition, such as diarrhea during or
following hospitalization, etc. In other examples, at 105, the
occurrence of one or more undesirable conditions, such as obesity,
etc., can be detected, triggering application of the Treatment
Model 100.
[0023] At 105, day 1, acute treatment ("TX") can be prescribed for
or administered to the patient. In an example, the acute treatment
can include administration of vancomycin (e.g., at a dose of 125
mg) four times daily for 4 days (QID.times.4 d). In other examples,
other doses can be used. However, the dosage can be less than
traditional antibiotic treatment due to the subsequent repopulation
of healthy or desired gut micriobiota from the fecal
bacteriotherapy to combat conditions or pathogens that would
otherwise remain in the gastrointestinal tract (e.g., clostridium
difficile spores, etc.).
[0024] At 110, day 1, a bacteriotherapy kit can be ordered, and in
certain examples, a donor can be identified. In an example, the
bacteriotherapy kit can be directed for use with a specific donor
and recipient. In many examples, for patients or intended
recipients having an improperly balanced or functioning gut
microbiota, it can be desirable to identify a donor having a
healthy gut microbiota similar to the patient's healthy gut
microbiota. Accordingly, a donor having a similar diet from a
similar or close geographic region, typically a spouse or close
relative, provides the best probability of quickly returning the
patient's healthy gut microbiota. However, in other examples, other
desired donor characteristics can be selected, such as a physical
characteristic, etc. In an example, the bacteriotherapy kit can be
overnight shipped to a clinician at a treatment facility, such as a
hospital or clinic, or otherwise quickly delivered to or stocked by
the clinician or at the treatment facility. In certain examples,
the kit can include a cooling mechanism, such as dry ice or one or
more other cooling mechanisms, configured to preserve subsequent
biological samples during transport.
[0025] At 115, day 2, the fecal sample can be taken from a proposed
donor, from the patient, or from both the proposed donor and the
patient. At 120, day 2, a blood sample can be taken from the
proposed donor, from the patient, or from both the proposed donor
and the patient. In an example, the fecal sample and the blood draw
can be stored in a bag (e.g., a fecal sample bag or a blood bag,
respectively) or one or more other storage mediums, such as a test
tube or one or more other storage containers. In certain examples,
to preserve the samples for testing and subsequent use, at least
one of the fecal sample or the blood draw can be cooled, such as by
using dry ice, etc. In an example, the fecal sample and the blood
draw can be overnight shipped or otherwise quickly delivered to a
facility for testing and processing the donor fecal sample.
[0026] At 125, day 3, the fecal sample can be processed for use in
fecal bacteriotherapy. In an example, the processing can include at
least one of blending or filtering the fecal sample and preparing
the sample for delivery to the patient, such as by nasogastric (NG)
tube, retention enema, colonoscopy delivery, or an oral tablet or
capsule, resistant to stomach acid (e.g., using an enteric coating,
etc.), configured to reach the gastrointestinal tract. Accordingly,
the processing can include placement into a sterile delivery
container, such as a bag configured for use with an NG tube or
retention enema. At 130, day 3, the fecal sample can be screened
for parasites or other pathogens, prior to or after processing. At
135, day 3, the blood draw can be screened for communicable
disease, to further ensure a healthy donor fecal sample.
[0027] In an example, following screening and processing, the
processed sample can be cooled and overnight shipped to the
clinician or caregiver at the treatment facility. At 140, day 4,
following the last dose of acute treatment (e.g., using
antibiotics), fecal bacteriotherapy can be provided to the patient
using the donor's processed fecal sample.
[0028] FIG. 2 illustrates generally an example of a bacteriotherapy
bank 200 including a cooling device (e.g., a refrigerator 201,
etc.) having a plurality of shelves (e.g., such as a first shelf
226, etc.) configured to store one or more processed and screened
donor fecal samples. In an example, the bacteriotherapy bank 200
can be configured to provide healthy donor fecal samples to a
single patient or a plurality of patients using at least a portion
of a fecal sample from a single healthy donor, or using at least a
portion of a fecal sample from a plurality of healthy donors. The
fecal bank allows for treatment of a first number of patients with
a smaller number of donors, reducing the cost of testing and
screening the donors and testing, screening, and processing the
donor fecal samples.
[0029] In an example, the bacteriotherapy bank 200 can be supplied
using a pool of anonymous, pre-screened donors, and can stock a
number of frozen, screened aliquots (single donor) for subsequent
use. In an example, a healthy donor can prepare fecal and blood
samples, unattached to a specific patient. In an example, the donor
fecal samples can be indexed using various donor information, or
using one or more characteristic of the donor fecal sample, such as
a geographic location of the donor, the source of the donor's diet,
the type of the donor's diet, the donor's ethnicity, body type,
age, sex, health status, or medical history, or other information
of the donor or the donor's fecal sample. In an example, people in
the same geographic location, or having similar diets, can have
similar gut microbiota. It can be desirable to match the gut
micriobiota of the healthy donor to the patient (e.g., similar
reasons to using a healthy family member for a donor). In an
example, the donor samples can be indexed using a computer indexing
system configured to store the various donor information or one or
more characteristic, can be indexed using a label on a bag or shelf
in the bacteriotherapy bank 200, or can be indexed using one or
more other indexing operations.
[0030] In an example, using the bacteriotherapy bank 200, exposure
and risk associated with the procedure can be limited by using a
donor for only a specified number of samples (e.g., to prevent the
accidental exposure of patients to infected donor material). In
other examples, it can be advantageous for an obese patient to
receive the gut microbiota of a healthy or thin donor, or of a
donor having a desired body composition or type, as the healthy or
thin donors gut flora may aid in weight management or management of
one or more other characteristic, such as weight gain, etc.
[0031] In certain examples, the bacteriotherapy bank 200 can store
material at temperatures of -20 degrees Celsius, the materials
including donor fecal samples, processed fecal samples, fecal
samples in delivery form, such as in an NG tube, vial, oral pill,
etc., or one or more other material.
[0032] FIG. 3 illustrates generally an example of a method 300 of
receiving and storing donor fecal samples. At 315, a donor fecal
sample is received. At 325, the donor fecal sample can be processed
and prepared for use in fecal bacteriotherapy, including, in
certain examples, testing or screening the donor fecal sample for
one or more diseases or conditions, or placing the processed donor
fecal sample in deliverable form. At 326, the processed donor fecal
sample can be stored prior to use, such as using a cooling
mechanism such as dry ice, a refrigerator, or one or more other
mechanisms.
[0033] FIG. 4 illustrates generally an example of a method 400 of
receiving, storing, and indexing donor fecal samples. At 415, a
plurality of donor fecal samples are received. At 417, at least one
characteristic of each donor fecal sample, or at least one
characteristic of each donor of each donor fecal sample, is
received. At 426, the donor fecal sample can be stored prior to
use, such as using a cooling mechanism such as dry ice, a
refrigerator, or one or more other mechanisms. At 427, the donor
fecal samples can be indexed using the at least one characteristic.
In certain examples, the donor fecal samples can be selected for
use with a patient using one or more shared or desired
characteristic.
[0034] In other examples, fecal bacteriotherapy (e.g., using the
bacteriotherapy bank or kit models described above) can be used to
treat or affect one or more other diseases or conditions. For
example, inflammatory bowel disease (IBD) (e.g., including Crohn's
disease, ulcerative colitis (UC), pouchitis, etc.) affects more
than one million people in the United States alone. Irritable bowel
syndrome accounts for nearly one-third of all gastrointestinal
office visits, affecting more than 36 million patients, with few
tools or treatments available to provide effective treatment. In
certain examples, patients afflicted with IBD or IBS could benefit
from a different gut microbiota providing different functions to
the gastrointestinal tract.
[0035] Further, fecal bacteriotherapy can be used to treat obesity.
Because the gut micriobiota in obese individuals is different from
non-obese individuals, and because gut micriobiota influences
energy metabolism, displacing the gut micriobiota of an obese
individual with the guy micriobiota of a non-obese individual.
ADDITIONAL NOTES & EXAMPLES
[0036] In Example 1, a method can optionally include receiving a
plurality of donor fecal samples from a plurality of donors,
receiving a characteristic of each of the plurality of donor fecal
samples, storing at least a portion of each of the plurality of
donor fecal samples, and indexing each of the plurality of donor
fecal samples using a characteristic of the respective donor fecal
sample.
[0037] In Example 2, a characteristic of the donor fecal sample of
Example 1 can optionally include a characteristic of the fecal
biota of the donor fecal sample.
[0038] In Example 3, the characteristic of the donor fecal sample
of any one or more of Examples 1-2 can optionally include at least
one of a physical characteristic or a dietary characteristic of the
donor.
[0039] In Example 4, the physical characteristic of the donor of
any one or more of Examples 1-3 can optionally include at least one
of a medical condition of the donor, a donor body mass index (BMI),
a donor weight, a combination of a donor height and the donor
weight, or a donor body fat percentage.
[0040] In Example 5, the physical characteristic of the donor of
any one or more of Examples 1-4 can optionally include a medical
condition of the donor, and the characteristic of the donor fecal
sample can optionally include the presence or absence of a medical
condition of the donor.
[0041] In Example 6, the medical condition of the donor of any one
or more of Examples 1-5 can optionally include at least one of a
metabolic disorder or a digestive disorder.
[0042] In Example 7, the metabolic disorder of any one or more of
Examples 1-6 can optionally include diabetes mellitus, and the
digestive disorder of any one or more of Examples 1-6 can
optionally include a gastrointestinal (GI) disorder including at
least one of irritable bowel syndrome (IBS) or inflammatory bowel
disease (IBD).
[0043] In Example 8, the dietary characteristic of the donor of any
one or more of Examples 1-7 can optionally include at least one of
a donor geographic consumption region, a donor diet, or a donor
religion.
[0044] In Example 9, the receiving the plurality of donor fecal
samples of any one or more of Examples 1-8 can optionally include
processing each of the plurality of donor fecal samples, including
homogenizing and filtering each of the donor fecal samples.
[0045] In Example 10, the receiving the plurality of donor fecal
samples of any one or more of Examples 1-9 can optionally include
receiving a plurality of donor fecal samples from a plurality of
screened donors.
[0046] In Example 11, any one or more of Examples 1-10 can
optionally include receiving a request for donor fecal matter, and
selecting a fecal dose using information from the request and the
indexed characteristics of the plurality of donor fecal samples,
wherein the fecal dose optionally includes at least a portion of at
least one of the stored donor fecal samples and is configured to be
provided to a patient.
[0047] In Example 12, any one or more of Examples 1-11 can
optionally include providing the fecal dose to the patient to
transfer a functioning biota in the patient.
[0048] In Example 13, the providing the fecal dose to the patient
to transfer the functioning biota in the patient of any one or more
of Examples 1-12 can optionally include to treat at least one of
antibiotic associated diarrhea or a Clostridium difficile
infection.
[0049] In Example 14, the receiving the request for donor fecal
matter of any one or more of Examples 1-13 can optionally include
receiving at least one desired characteristic.
[0050] In Example 15, the receiving the at least one desired
characteristic of any one or more of Examples 1-14 can optionally
include receiving at least one of a desired physical characteristic
or a desired dietary characteristic of the donor.
[0051] In Example 16, the storing at least a portion of each of the
plurality of donor fecal samples of any one or more of Examples
1-15 can optionally include storing at least a portion of each of
the plurality of donor fecal samples in a patient-deliverable
form.
[0052] In Example 17, the storing at least a portion of each of the
plurality of donor fecal samples in the patient-deliverable form of
any one or more of Examples 1-16 can optionally include storing at
least a portion of each of the plurality of donor fecal samples in
at least one of an ingestible capsule configured to be delivered to
an intestinal tract of a patient through the mouth of the patient,
an ampule configured for use in an antegrade gastrointestinal (GI)
delivery approach to the intestinal tract of the patient, or an
ampule configured for use in a retraograde GI delivery approach to
the intestinal tract of the patient.
[0053] In Example 18, the receiving the plurality of donor fecal
samples of any one or more of Examples 1-17 can optionally include
receiving wet fecal samples and processing each of the received
donor fecal samples, wherein the processing each of the received
donor fecal samples of any one or more of Examples 1-17 can
optionally include homogenizing, filtering, and adding a
cryoprotectant to each of the donor fecal samples, and wherein the
storing at least a portion of each of the plurality of donor fecal
samples in a patient-deliverable form of any one or more of
Examples 1-17 can optionally include freezing each of the plurality
of donor fecal samples in the patient-deliverable form to maintain
viability of the biota of the donor fecal samples.
[0054] In Example 19, any one or more of Examples 1-18 can
optionally include preparing a plurality of fecal doses using one
or more donor fecal samples from a single donor, wherein the
plurality of fecal doses are configured to be provided to a
plurality of patients.
[0055] In Example 20, any one or more of Examples 1-19 can
optionally include preparing a fecal dose configured to be provided
to a single patient using a plurality of donor fecal samples.
[0056] In Example 21, the preparing the fecal dose of any one or
more of Examples 1-20 can optionally include combining at least a
portion of a first donor fecal sample and a second donor fecal
sample, wherein the first and second donor samples have at least
one different characteristic.
[0057] In Example 22, a fecal bank can optionally include a
plurality of fecal storage containers configured to store each of a
plurality of donor fecal sample and an indexing system, configured
to associate, for each of the plurality of donor fecal samples, a
characteristic of the donor fecal sample with the respective donor
fecal sample.
[0058] In Example 23, the characteristic of the donor fecal sample
of any one or more of Examples 1-22 can optionally include at least
one of a physical characteristic or a dietary characteristic of the
donor.
[0059] In Example 24, the characteristic of the donor fecal sample
of any one or more of Examples 1-23 can optionally include a
characteristic of the fecal biota of the donor fecal sample.
[0060] In Example 25, the physical characteristic of the donor of
any one or more of Examples 1-24 can optionally include at least
one of a medical condition of the donor, a donor body mass index
(BMI), a donor weight, a combination of a donor height and the
donor weight, or a donor body fat percentage.
[0061] In Example 26, the physical characteristic of the donor of
any one or more of Examples 1-25 can optionally include a medical
condition of the donor and wherein the characteristic of the donor
fecal sample includes the presence or absence of a medical
condition of the donor.
[0062] In Example 27, the medical condition of the donor of any one
or more of Examples 1-26 can optionally include at least one of a
metabolic disorder or a digestive disorder, wherein the metabolic
disorder includes diabetes mellitus, and wherein the digestive
disorder includes a gastrointestinal (GI) disorder including at
least one of irritable bowel syndrome (IBS) or inflammatory bowel
disease (IBD).
[0063] In Example 28, the dietary characteristic of the donor of
any one or more of Examples 1-27 can optionally include at least
one of a donor geographic consumption region, a donor diet, or a
donor religion.
[0064] In Example 29, the plurality of donor fecal samples of any
one or more of Examples 1-28 can optionally include wet fecal
samples and wherein the plurality of fecal storage containers are
configured to store frozen, wet donor fecal samples to maintain
viability of the biota of the donor fecal samples.
[0065] In Example 30, the plurality of fecal storage containers of
any one or more of Examples 1-29 can optionally include a plurality
of patient-deliverable fecal storage containers.
[0066] In Example 31, the plurality of patient-deliverable fecal
storage containers of any one or more of Examples 1-30 can
optionally include at least one of an ingestible capsule configured
to be delivered to an intestinal tract of a patient through the
mouth of the patient, an ampule configured for use in an antegrade
gastrointestinal (GI) delivery approach to the intestinal tract of
the patient, or an ampule configured for use in a retraograde GI
delivery approach to the intestinal tract of the patient.
[0067] In Example 32, a system can include, or can optionally be
combined with any portion or combination of any portions of any one
or more of Examples 1-31 to include, subject matter that can
include means for performing any one or more of the functions of
Examples 1-31, or a machine-readable medium including instructions
that, when performed by a machine, cause the machine to perform any
one or more of the functions of Examples 1-31.
[0068] In Example 33, a method optionally includes receiving a
donor fecal sample from a donor, processing the donor fecal sample,
wherein the processing includes homogenizing the donor fecal
sample, and storing at least a portion of the processed donor fecal
sample.
[0069] In Example 34, the receiving the donor fecal sample from the
donor of any one or more of Examples 1-33 can optionally include
receiving a plurality of donor fecal samples from a plurality of
donors, wherein the processing the donor fecal sample of any one or
more of Examples 1-33 can optionally include processing each of the
plurality of donor fecal samples, wherein the processing of any one
or more of Examples 1-33 can optionally include homogenizing each
of the donor fecal samples, and wherein the storing at least a
portion of the processed donor fecal sample of any one or more of
Examples 1-33 can optionally include storing at least a portion of
each of the plurality of processed donor fecal samples.
[0070] In Example 35, any one or more of Examples 1-34 optionally
includes receiving a characteristic of each of the plurality of
donor fecal samples, and indexing each of the plurality of donor
fecal samples using a characteristic of the respective donor fecal
sample.
[0071] In Example 36, the characteristic of the donor fecal sample
of any one or more of Examples 1-35 can optionally include a
characteristic of the fecal biota of the donor fecal sample.
[0072] In Example 37, the characteristic of the donor fecal sample
of any one or more of Examples 1-36 can optionally include at least
one of a physical characteristic or a dietary characteristic of the
donor.
[0073] In Example 38, the physical characteristic of the donor of
any one or more of Examples 1-37 can optionally include at least
one of a medical condition of the donor, a donor body mass index
(BMI), a donor weight, a combination of a donor height and the
donor weight, or a donor body fat percentage.
[0074] In Example 39, the physical characteristic of the donor of
any one or more of Examples 1-38 can optionally include a medical
condition of the donor, and wherein the characteristic of the donor
fecal sample of any one or more of Examples 1-38 can optionally
include the presence or absence of a medical condition of the
donor.
[0075] In Example 40, the medical condition of the donor of any one
or more of Examples 1-39 can optionally include at least one of a
metabolic disorder or a digestive disorder, wherein the metabolic
disorder of any one or more of Examples 1-39 can optionally include
diabetes mellitus, and wherein the digestive disorder includes a
gastrointestinal (GI) disorder of any one or more of Examples 1-39
can optionally include at least one of irritable bowel syndrome
(IBS) or inflammatory bowel disease (IBD).
[0076] In Example 41, the dietary characteristic of the donor of
any one or more of Examples 1-40 can optionally include at least
one of a donor geographic consumption region, a donor diet, or a
donor religion.
[0077] In Example 42, any one or more of Examples 1-41 can
optionally include receiving a request for donor fecal matter, and
selecting a fecal dose using information from the request and the
indexed characteristics of the plurality of donor fecal samples,
wherein the fecal dose of any one or more of Examples 1-41 can
optionally include at least a portion of at least one of the stored
donor fecal samples and is configured to be provided to a
patient.
[0078] In Example 43, any one or more of Examples 1-42 can
optionally include providing the fecal dose to the patient to
transfer a functioning biota in the patient.
[0079] In Example 44, the providing the fecal dose to the patient
to transfer the functioning biota in the patient of any one or more
of Examples 1-43 can optionally include to treat at least one of
antibiotic associated diarrhea or a Clostridium difficile
infection.
[0080] In Example 45, the receiving the request for donor fecal
matter of any one or more of Examples 1-44 can optionally include
receiving at least one desired characteristic.
[0081] In Example 46, the receiving the at least one desired
characteristic of any one or more of Examples 1-45 can optionally
include receiving at least one of a desired physical characteristic
or a desired dietary characteristic of the donor.
[0082] In Example 47, any one or more of Examples 1-46 can
optionally include preparing a fecal dose configured to be provided
to a single patient using a plurality of processed donor fecal
samples.
[0083] In Example 48, the preparing the fecal dose of any one or
more of Examples 1-47 can optionally include combining at least a
portion of a first donor fecal sample and a second donor fecal
sample, wherein the first and second donor samples have at least
one different characteristic.
[0084] In Example 49, the processing the donor fecal sample of any
one or more of Examples 1-48 can optionally include filtering the
donor fecal sample.
[0085] In Example 50, the receiving the donor fecal sample of any
one or more of Examples 1-49 can optionally include receiving a
donor fecal sample from a screened donor.
[0086] In Example 51, the storing at least a portion of the
processed donor fecal sample of any one or more of Examples 1-50
can optionally include storing at least a portion of the processed
donor fecal sample in a patient-deliverable form.
[0087] In Example 52, the storing at least a portion of the
processed donor fecal sample in the patient-deliverable form of any
one or more of Examples 1-51 can optionally include storing at
least a portion of each of the plurality of donor fecal samples in
at least one of an ingestible capsule configured to be delivered to
an intestinal tract of a patient through the mouth of the patient,
an ampule configured for use in an antegrade gastrointestinal (GI)
delivery approach to the intestinal tract of the patient, or an
ampule configured for use in a retraograde GI delivery approach to
the intestinal tract of the patient.
[0088] In Example 53, the receiving the donor fecal sample of any
one or more of Examples 1-52 can optionally include receiving a wet
fecal sample, wherein the processing the donor fecal sample of any
one or more of Examples 1-52 can optionally include adding a
cryoprotectant to the donor fecal sample, and wherein the storing
at least a portion of the processed donor fecal sample in the
patient-deliverable form of any one or more of Examples 1-52 can
optionally include freezing at least a portion of the processed
donor fecal sample in the patient-deliverable form to maintain
viability of the biota of the donor fecal sample.
[0089] In Example 54, the adding the cryoprotectant of any one or
more of Examples 1-53 can optionally include at least one of
glycol, glycerol, dimethyl sulfoxide (DMSO), dairy milk, or soy
milk.
[0090] In Example 55, any one or more of Examples 1-54 can
optionally include preparing a plurality of fecal doses using one
or more processed donor fecal samples from a single donor, wherein
the plurality of fecal doses are configured to be provided to a
plurality of patients.
[0091] In Example 56, at least a portion of the stored donor fecal
sample of any one or more of Examples 1-55 can optionally be
configured to be provided to an intestinal tract of a patient that
is not the donor to a condition of the patient.
[0092] In Example 57, the condition of any one or more of Examples
1-56 can optionally include at least one of a disease or an
infection of or in the patient.
[0093] In Example 58, the condition of any one or more of Examples
1-57 can optionally include at least one of antibiotic associated
diarrhea of the patient or a Clostridium difficile infection in the
patient.
[0094] In Example 59, a system can include, or can optionally be
combined with any portion or combination of any portions of any one
or more of Examples 1-58 to include, subject matter that can
include means for performing any one or more of the functions of
Examples 1-58, or a machine-readable medium including instructions
that, when performed by a machine, cause the machine to perform any
one or more of the functions of Examples 1-58.
[0095] In Example 60, a method can optionally include receiving a
donor fecal sample from a donor, and storing at least a portion of
the donor fecal sample in a patient-deliverable form.
[0096] In Example 61, the receiving the donor fecal sample of any
one or more of Examples 1-60 can optionally include receiving a
plurality of donor fecal samples from a plurality of donors, and
wherein the storing at least a portion of the donor fecal sample in
the patient-deliverable from of any one or more of Examples 1-60
can optionally include storing at least a portion of each of the
plurality of processed donor fecal samples in a patient-deliverable
form.
[0097] In Example 62, any one or more of Examples 1-61 can
optionally include receiving a characteristic of each of the
plurality of donor fecal samples, and indexing each of the
plurality of donor fecal samples using a characteristic of the
respective donor fecal sample.
[0098] In Example 63, the characteristic of the donor fecal sample
of any one or more of Examples 1-62 can optionally include a
characteristic of the fecal biota of the donor fecal sample.
[0099] In Example 64, the characteristic of the donor fecal sample
of any one or more of Examples 1-63 can optionally include at least
one of a physical characteristic or a dietary characteristic of the
donor.
[0100] In Example 65, the physical characteristic of the donor of
any one or more of Examples 1-64 can optionally include at least
one of a medical condition of the donor, a donor body mass index
(BMI), a donor weight, a combination of a donor height and the
donor weight, or a donor body fat percentage.
[0101] In Example 66, the physical characteristic of the donor of
any one or more of Examples 1-65 can optionally include a medical
condition of the donor and wherein the characteristic of the donor
fecal sample of any one or more of Examples 1-65 can optionally
include the presence or absence of a medical condition of the
donor.
[0102] In Example 67, the medical condition of the donor of any one
or more of Examples 1-66 can optionally include at least one of a
metabolic disorder or a digestive disorder, wherein the metabolic
disorder of any one or more of Examples 1-66 can optionally include
diabetes mellitus, and wherein the digestive disorder of any one or
more of Examples 1-66 can optionally include a gastrointestinal
(GI) disorder including at least one of irritable bowel syndrome
(IBS) or inflammatory bowel disease (IBD).
[0103] In Example 68, the dietary characteristic of the donor of
any one or more of Examples 1-67 can optionally include at least
one of a donor geographic consumption region, a donor diet, or a
donor religion.
[0104] In Example 69, any one or more of Examples 1-68 can
optionally include receiving a request for donor fecal matter and
selecting a fecal dose using information from the request and the
indexed characteristics of the plurality of donor fecal samples,
wherein the fecal dose includes at least a portion of at least one
of the stored donor fecal samples and is configured to be provided
to a patient.
[0105] In Example 70, any one or more of Examples 1-69 can
optionally include providing the fecal dose to the patient to
transfer a functioning biota in the patient.
[0106] In Example 71, the providing the fecal dose to the patient
to transfer the functioning biota in the patient of any one or more
of Examples 1-70 can optionally include to treat at least one of
antibiotic associated diarrhea or a Clostridium difficile
infection.
[0107] In Example 72, the receiving the request for donor fecal
matter of any one or more of Examples 1-71 can optionally include
receiving at least one desired characteristic.
[0108] In Example 73, the receiving the at least one desired
characteristic of any one or more of Examples 1-72 can optionally
include receiving at least one of a desired physical characteristic
or a desired dietary characteristic of the donor.
[0109] In Example 74, any one or more of Examples 1-73 can
optionally include preparing a fecal dose configured to be provided
to a single patient using a plurality of processed donor fecal
samples.
[0110] In Example 75, the preparing the fecal dose of any one or
more of Examples 1-74 can optionally include combining at least a
portion of a first donor fecal sample and a second donor fecal
sample, wherein the first and second donor samples have at least
one different characteristic.
[0111] In Example 76, the receiving the donor fecal sample of any
one or more of Examples 1-75 can optionally include receiving a
donor fecal sample from a screened donor.
[0112] In Example 77, any one or more of Examples 1-76 can
optionally include processing the received donor fecal sample,
wherein the processing includes homogenizing the donor fecal
sample, wherein the storing at least a portion of the donor fecal
sample in the patient-deliverable form of any one or more of
Examples 1-76 can optionally include storing at least a portion of
the processed donor fecal sample.
[0113] In Example 78, the processing the donor fecal sample of any
one or more of Examples 1-77 can optionally include filtering the
donor fecal sample.
[0114] In Example 79, the receiving the donor fecal sample of any
one or more of Examples 1-78 can optionally include receiving a wet
fecal sample, wherein the processing the donor fecal sample of any
one or more of Examples 1-78 can optionally include adding a
cryoprotectant to the donor fecal sample, and wherein the storing
at least a portion of the processed donor fecal sample in the
patient-deliverable form of any one or more of Examples 1-78 can
optionally include freezing at least a portion of the processed
donor fecal sample in the patient-deliverable form to maintain
viability of the biota of the donor fecal sample.
[0115] In Example 80, any one or more of Examples 1-79 can
optionally include preparing a plurality of fecal doses using one
or more processed donor fecal samples from a single donor, wherein
the plurality of fecal doses are configured to be provided to a
plurality of patients.
[0116] In Example 81, the storing at least a portion of the donor
fecal sample in the patient-deliverable form of any one or more of
Examples 1-80 can optionally include storing at least a portion of
the donor fecal sample in at least one of an ingestible capsule
configured to be delivered to an intestinal tract of a patient
through the mouth of the patient, an ampule configured for use in
an antegrade gastrointestinal (GI) delivery approach to the
intestinal tract of the patient, or an ampule configured for use in
a retrograde GI delivery approach to the intestinal tract of the
patient.
[0117] In Example 82, the storing at least a portion of the donor
fecal sample in the ingestible capsule of any one or more of
Examples 1-81 can optionally include storing at least a portion of
the donor fecal sample in a gastro-resistant capsule.
[0118] In Example 83, any one or more of Examples 1-82 can
optionally include a patient-deliverable fecal storage container
configured to store at least a portion of a processed donor fecal
sample configured to be provided to an intestinal tract of a
patient that is not the donor to treat a condition of the
patient.
[0119] In Example 84, of any one or more of Examples 1-83 can
optionally include a plurality of patient-deliverable fecal storage
containers configured to store at least a portion of each of a
plurality of processed donor fecal samples, and an indexing system,
configured to associate, for each of the plurality of processed
donor fecal samples, a characteristic of the processed donor fecal
sample with the respective processed donor fecal sample.
[0120] In Example 85, the characteristic of the donor fecal sample
of any one or more of Examples 1-84 can optionally include a
characteristic of the fecal biota of the donor fecal sample.
[0121] In Example 86, the characteristic of the donor fecal sample
of any one or more of Examples 1-85 can optionally include at least
one of a physical characteristic or a dietary characteristic of the
donor.
[0122] In Example 87, the physical characteristic of the donor of
any one or more of Examples 1-86 can optionally include at least
one of a medical condition of the donor, a donor body mass index
(BMI), a donor weight, a combination of a donor height and the
donor weight, or a donor body fat percentage.
[0123] In Example 88, the physical characteristic of the donor of
any one or more of Examples 1-87 can optionally include a medical
condition of the donor, wherein the characteristic of the donor
fecal sample of any one or more of Examples 1-87 can optionally
include the presence or absence of a medical condition of the
donor.
[0124] In Example 89, the medical condition of the donor of any one
or more of Examples 1-88 can optionally include at least one of a
metabolic disorder or a digestive disorder, wherein the metabolic
disorder of any one or more of Examples 1-88 can optionally include
diabetes mellitus, and wherein the digestive disorder of any one or
more of Examples 1-88 can optionally include a gastrointestinal
(GI) disorder including at least one of irritable bowel syndrome
(IBS) or inflammatory bowel disease (IBD).
[0125] In Example 90, the dietary characteristic of the donor of
any one or more of Examples 1-89 can optionally include at least
one of a donor geographic consumption region, a donor diet, or a
donor religion.
[0126] In Example 91, the processed donor fecal sample of any one
or more of Examples 1-90 can optionally include a wet fecal sample,
and wherein the patient-deliverable fecal storage container of any
one or more of Examples 1-90 can optionally be configured to store
at least a portion of a frozen, wet donor fecal sample to maintain
viability of the biota of the donor fecal sample.
[0127] In Example 92, the patient-deliverable fecal storage
container of any one or more of Examples 1-91 can optionally
include at least one of an ingestible capsule configured to be
delivered to an intestinal tract of a patient through the mouth of
the patient, an ampule configured for use in an antegrade
gastrointestinal (GI) delivery approach to the intestinal tract of
the patient, or an ampule configured for use in a retraograde GI
delivery approach to the intestinal tract of the patient.
[0128] In Example 93, the condition of the patient of any one or
more of Examples 1-92 can optionally include at least one of a
disease or an infection of or in the patient.
[0129] In Example 94, the condition of the patient of any one or
more of Examples 1-93 can optionally include at least one of
antibiotic associated diarrhea of the patient or a Clostridium
difficile infection in the patient.
[0130] In Example 95, a system can include, or can optionally be
combined with any portion or combination of any portions of any one
or more of Examples 1-94 to include, subject matter that can
include means for performing any one or more of the functions of
Examples 1-94, or a machine-readable medium including instructions
that, when performed by a machine, cause the machine to perform any
one or more of the functions of Examples 1-94.
[0131] In Example 96, a method can optionally include selecting a
fecal dose for treatment of a condition of a patient, wherein the
fecal dose includes at least a portion of a donor fecal sample from
a donor and is configured to be provided to an intestinal tract of
the patient, wherein the patient is not the donor, and wherein the
selecting the fecal dose includes using a characteristic of the
donor.
[0132] In Example 97, the condition of the patient of any one or
more of Examples 1-96 can optionally include a patient weight above
a desired target weight.
[0133] In Example 98, the condition of the patient of any one or
more of Examples 1-97 can optionally include obesity.
[0134] In Example 99, the characteristic of the donor fecal sample
of any one or more of Examples 1-98 can optionally include a
characteristic of the fecal biota of the donor fecal sample.
[0135] In Example 100, the characteristic of the donor of any one
or more of Examples 1-99 can optionally include at least one of a
physical characteristic or a dietary characteristic of the
donor.
[0136] In Example 101, the physical characteristic of the donor of
any one or more of Examples 1-100 can optionally include at least
one of a donor body mass index (BMI), a donor weight, a combination
of a donor height and the donor weight, or a donor body fat
percentage.
[0137] In Example 102, the physical characteristic of the donor of
any one or more of Examples 1-101 can optionally include a medical
condition of the donor, and wherein the characteristic of the donor
fecal sample of any one or more of Examples 1-101 can optionally
include the presence or absence of a medical condition of the
donor.
[0138] In Example 103, the dietary characteristic of the donor of
any one or more of Examples 1-102 can optionally include at least
one of a donor geographic consumption region, a donor diet, or a
donor religion.
[0139] In Example 104, any one or more of Examples 1-103 can
optionally include providing information about the dietary
characteristic of the donor to the patient, wherein the dietary
characteristic includes a donor diet.
[0140] In Example 105, the characteristic of the donor of any one
or more of Examples 1-104 can optionally include the physical
characteristic of the donor and the dietary characteristic of the
donor.
[0141] In Example 106, the fecal dose of any one or more of
Examples 1-105 can optionally include at least a portion of a
plurality of donor fecal samples from a plurality of donors, and
wherein the selecting the fecal dose of any one or more of Examples
1-105 can optionally include using at least one characteristic of
the plurality of donors.
[0142] In Example 107, any one or more of Examples 1-106 can
optionally include receiving the donor fecal sample from the donor,
processing the donor fecal sample, wherein the processing of any
one or more of Examples 1-106 can optionally include homogenizing
the donor fecal sample, and wherein the fecal dose of any one or
more of Examples 1-106 can optionally include at least a portion of
the processed donor fecal sample.
[0143] In Example 108, the receiving the donor fecal sample from
the donor of any one or more of Examples 1-107 can optionally
include receiving a plurality of donor fecal samples from a
plurality of donors, wherein the processing the donor fecal sample
of any one or more of Examples 1-107 can optionally include
processing each of the plurality of donor fecal samples, wherein
the processing of any one or more of Examples 1-107 can optionally
include homogenizing each of the donor fecal samples, and storing
at least a portion of each of the plurality of processed donor
fecal samples.
[0144] In Example 109, any one or more of Examples 1-108 can
optionally include receiving a characteristic of each of the
plurality of donor fecal samples, and indexing each of the
plurality of donor fecal samples using a characteristic of the
respective donor fecal sample.
[0145] In Example 110, the fecal dose of any one or more of
Examples 1-109 can optionally include at least a portion of at
least one of the stored processed donor fecal samples and is
configured to be provided to a patient
[0146] In Example 111, the receiving the donor fecal sample of any
one or more of Examples 1-110 can optionally include receiving a
wet fecal sample, wherein the processing the donor fecal sample
includes adding a cryoprotectant to the donor fecal sample, storing
at least a portion of the processed donor fecal sample in a
patient-deliverable form, and wherein the storing at least a
portion of the processed donor fecal sample in the
patient-deliverable form of any one or more of Examples 1-110 can
optionally include freezing at least a portion of the processed
donor fecal sample in the patient-deliverable form to maintain
viability of the biota of the donor fecal sample.
[0147] In Example 112, any one or more of Examples 1-111 can
optionally include receiving the donor fecal sample from the donor,
storing at least a portion of the donor fecal sample in a
patient-deliverable form, and wherein the selecting the fecal dose
of any one or more of Examples 1-111 can optionally include
selecting at least one stored donor fecal sample.
[0148] In Example 113, the storing at least a portion of the donor
fecal sample in the patient-deliverable form of any one or more of
Examples 1-112 can optionally include storing at least a portion of
the donor fecal sample in at least one of an ingestible capsule
configured to be delivered to an intestinal tract of a patient
through the mouth of the patient, an ampule configured for use in
an antegrade gastrointestinal (GI) delivery approach to the
intestinal tract of the patient, or an ampule configured for use in
a retrograde GI delivery approach to the intestinal tract of the
patient.
[0149] In Example 114, the condition of any one or more of Examples
1-113 can optionally include at least one of a disease or an
infection of or in the patient.
[0150] In Example 115, the condition of any one or more of Examples
1-116 can optionally include at least one of antibiotic associated
diarrhea of the patient or a Clostridium difficile infection in the
patient.
[0151] In Example 116, any one or more of Examples 1-115 can
optionally include preparing a plurality of fecal doses using one
or more donor fecal samples from a single donor, wherein the
plurality of fecal doses are configured to be provided to a
plurality of patients
[0152] In Example 117, any one or more of Examples 1-116 can
optionally include receiving a plurality of donor fecal samples
from a plurality of donors, receiving a characteristic of each of
the plurality of donors, storing at least a portion of each of the
plurality of donor fecal samples, indexing each of the plurality of
donor fecal samples using at least one characteristic of the
respective donors, receiving a request for donor fecal matter, and
selecting a fecal dose for treatment of a condition of a patient in
response to the received request for donor fecal matter, wherein
the fecal dose of any one or more of Examples 1-116 can optionally
include at least a portion of a stored donor fecal sample and is
configured to be provided to an intestinal tract of the patient,
wherein the patient is not the donor, wherein the condition of the
patient of any one or more of Examples 1-116 can optionally include
a patient weight above a desired patient weight, and wherein the
selecting the fecal dose includes using a physical characteristic
of the donor of the fecal dose and a dietary characteristic of the
donor of the fecal dose.
[0153] In Example 118, the physical characteristic of the donor of
any one or more of Examples 1-117 can optionally include at least
one of a donor body mass index (BMI), a donor weight, a combination
of a donor height and the donor weight, or a donor body fat
percentage.
[0154] In Example 119, the dietary characteristic of the donor of
any one or more of Examples 1-118 can optionally include at least
one of a donor geographic consumption region, a donor diet, or a
donor religion.
[0155] In Example 120, any one or more of Examples 1-119 can
optionally include providing information about the dietary
characteristic of the donor to the patient, wherein the dietary
characteristic includes a donor diet.
[0156] In Example 121, the fecal dose of any one or more of
Examples 1-120 can optionally include at least a portion of a
plurality of donor fecal samples from a plurality of donors, and
wherein the selecting the fecal dose of any one or more of Examples
1-120 can optionally include using a physical characteristic of the
plurality of donors of the fecal dose and a dietary characteristic
of the plurality of donors of the fecal dose.
[0157] In Example 122, a system can include, or can optionally be
combined with any portion or combination of any portions of any one
or more of Examples 1-121 to include, subject matter that can
include means for performing any one or more of the functions of
Examples 1-121, or a machine-readable medium including instructions
that, when performed by a machine, cause the machine to perform any
one or more of the functions of Examples 1-121.
[0158] In Example 123, a method can optionally include providing a
kit to a clinician, the kit enabling the clinician to store and
transport a donor fecal sample from a donor to a central facility,
receiving the frozen donor fecal sample from the clinician at the
central facility, screening the donor fecal sample for at least one
of a parasite, a pathogen, a disease, or an unhealthy condition of
the donor, and providing a fecal dose to the clinician to be
administered to a patient, wherein the fecal dose includes at least
a portion of at least one donor fecal sample.
[0159] In Example 124, any one or more of Examples 1-123 can
optionally include, receiving a characteristic of the donor fecal
sample, storing at least a portion the donor fecal sample, and
indexing the donor fecal sample using the characteristic of the
donor fecal sample.
[0160] In Example 125, the characteristic of the donor fecal sample
of any one or more of Examples 1-124 can optionally include a
characteristic of the fecal biota of the donor fecal sample.
[0161] In Example 126, the characteristic of the donor fecal sample
of any one or more of Examples 1-125 can optionally include at
least one of a physical characteristic or a dietary characteristic
of the donor.
[0162] In Example 127, the physical characteristic of the donor of
any one or more of Examples 1-126 can optionally include at least
one of a medical condition of the donor, a donor body mass index
(BMI), a donor weight, a combination of a donor height and the
donor weight, or a donor body fat percentage.
[0163] In Example 128, the physical characteristic of the donor of
any one or more of Examples 1-127 can optionally include a medical
condition of the donor, and wherein the characteristic of the donor
fecal sample of any one or more of Examples 1-127 can optionally
include the presence or absence of a medical condition of the
donor.
[0164] In Example 129, the medical condition of the donor of any
one or more of Examples 1-128 can optionally include at least one
of a metabolic disorder or a digestive disorder.
[0165] In Example 130, the metabolic disorder of any one or more of
Examples 1-129 can optionally include diabetes mellitus, and
wherein the digestive disorder of any one or more of Examples 1-129
can optionally include a gastrointestinal (GI) disorder including
at least one of irritable bowel syndrome (IBS) or inflammatory
bowel disease (IBD).
[0166] In Example 131, the dietary characteristic of the donor of
any one or more of Examples 1-130 can optionally include at least
one of a donor geographic consumption region, a donor diet, or a
donor religion.
[0167] In Example 132, the providing the kit to the clinician of
any one or more of Examples 1-131 can optionally include providing
a plurality of kits to one or more clinicians, wherein the
receiving the frozen donor fecal sample from the clinician of any
one or more of Examples 1-131 can optionally include receiving a
plurality of frozen donor fecal samples from one or more
clinicians, wherein the screening the donor fecal sample of any one
or more of Examples 1-131 can optionally include screening a
plurality of donor fecal samples, wherein the receiving the
characteristic of the donor fecal sample of any one or more of
Examples 1-131 can optionally include receiving a characteristic of
each of the plurality of donor fecal samples, wherein the storing
at least a portion of the donor fecal sample of any one or more of
Examples 1-131 can optionally include storing at least a portion of
the plurality of donor fecal samples, and wherein the indexing the
donor fecal sample of any one or more of Examples 1-131 can
optionally include indexing each the plurality of donor fecal
samples using a characteristic of the respective donor fecal
sample.
[0168] In Example 133, any one or more of Examples 1-132 can
optionally include receiving a request for donor fecal matter, and
selecting the fecal dose to be provided to the patient from a
plurality of stored fecal doses using information from the request
and the indexed characteristics of the plurality of donor fecal
samples.
[0169] In Example 134, the receiving the request for donor fecal
matter of any one or more of Examples 1-133 can optionally include
receiving at least one desired characteristic.
[0170] In Example 135, the receiving the at least one desired
characteristic of any one or more of Examples 1-136 can optionally
include receiving at least one of a desired physical characteristic
or a desired dietary characteristic of the donor.
[0171] In Example 136, the storing at least a portion the donor
fecal sample of any one or more of Examples 1-135 can optionally
include storing at least a portion of the donor fecal sample in a
patient-deliverable form.
[0172] In Example 137, the storing at least a portion of the donor
fecal sample in a patient-deliverable form of any one or more of
Examples 1-136 can optionally include storing at least a portion of
each of the plurality of donor fecal samples in at least one of an
ingestible capsule configured to be delivered to an intestinal
tract of a patient through the mouth of the patient, an ampule
configured for use in an antegrade gastrointestinal (GI) delivery
approach to the intestinal tract of the patient, or an ampule
configured for use in a retraograde GI delivery approach to the
intestinal tract of the patient.
[0173] In Example 138, any one or more of Examples 1-137 can
optionally include processing the donor fecal sample, the
processing the donor fecal sample of any one or more of Examples
1-137 can optionally include homogenizing and filtering the donor
fecal sample.
[0174] In Example 139, the processing the donor fecal sample of any
one or more of Examples 1-138 can optionally include adding a
cryoprotectant to the donor fecal sample, and wherein the storing
at least a portion of the donor fecal sample of any one or more of
Examples 1-138 can optionally include freezing the donor fecal
sample to maintain viability of the biota of the donor fecal
sample.
[0175] In Example 140, any one or more of Examples 1-139 can
optionally include providing the fecal dose to the patient to
transfer a functioning biota in the patient.
[0176] In Example 141, the providing the fecal dose to the patient
to transfer the functioning biota in the patient of any one or more
of Examples 1-140 can optionally include to treat at least one of
antibiotic associated diarrhea or a Clostridium difficile
infection.
[0177] In Example 142, any one or more of Examples 1-141 can
optionally include providing a kit to the clinician, the kit
enabling the clinician to store and transport a donor blood sample
from the donor to the central facility, receiving the frozen donor
blood sample from the clinician at the central facility, and
screening the donor blood sample for at least one of a parasite, a
pathogen, a disease, or an unhealthy condition of the donor.
[0178] In Example 143, the providing the kit to the clinician of
any one or more of Examples 1-142 can optionally include providing
a kit enabling the clinician to store and transport a wet fecal
sample from the patient to the central facility.
[0179] In Example 144, the providing the kit to the clinician of
any one or more of Examples 1-143 can optionally include providing
a kit enabling the clinician to store, freeze, and transport the
wet fecal sample from the patient to the central facility.
[0180] In Example 145, a system can include, or can optionally be
combined with any portion or combination of any portions of any one
or more of Examples 1-144 to include, subject matter that can
include means for performing any one or more of the functions of
Examples 1-144, or a machine-readable medium including instructions
that, when performed by a machine, cause the machine to perform any
one or more of the functions of Examples 1-144.
[0181] In Example 146, a method can optionally include providing a
kit to a clinician, the kit enabling the clinician to store and
transport a patient fecal sample from a patient to a central
facility, receiving the frozen patient fecal sample from the
clinician at the central facility, and providing a fecal dose to
the clinician to be administered to the patient, wherein the fecal
dose of any one or more of Examples 1-145 can optionally include at
least a portion of at least one donor fecal sample.
[0182] In Example 147, any one or more of Examples 1-146 can
optionally include receiving a characteristic of the patient fecal
sample, and selecting at least one of a plurality of stored donor
fecal samples to be provided to the patient using the received
characteristic.
[0183] In Example 148, any one or more of Examples 1-147 can
optionally include receiving a desired characteristic, and
selecting at least one of a plurality of stored donor fecal samples
to be provided to the patient using the desired characteristic.
[0184] In Example 149, the providing the fecal dose to the
clinician of any one or more of Examples 1-148 can optionally
include providing the fecal dose in a patient-deliverable form,
including at least one of an ingestible capsule configured to be
delivered to an intestinal tract of the patient through the mouth
of the patient, an ampule configured for use in an antegrade
gastrointestinal (GI) delivery approach to the intestinal tract of
the patient, or an ampule configured for use in a retraograde GI
delivery approach to the intestinal tract of the patient.
[0185] In Example 150, the providing the kit to the clinician of
any one or more of Examples 1-149 can optionally include providing
a sterile kit to the clinician.
[0186] In Example 151, the providing the kit to the clinician and
the providing the fecal dose to the clinician of any one or more of
Examples 1-150 can optionally include using expedited shipping.
[0187] In Example 152, the expedited shipping of any one or more of
Examples 1-151 can optionally include overnight shipping.
[0188] In Example 153, any one or more of Examples 1-152 can
optionally include screening the patient fecal sample for at least
one of a parasite, a pathogen, a disease, or an unhealthy condition
of the patient.
[0189] In Example 154, any one or more of Examples 1-153 can
optionally include providing a kit to the clinician, the kit
enabling the clinician to store and transport a patient blood
sample from the patient to the central facility, and screening the
patient blood sample for at least one of a parasite, a pathogen, a
disease, or an unhealthy condition of the patient.
[0190] In Example 155, the providing the kit to the clinician of
any one or more of Examples 1-154 can optionally include providing
a kit enabling the clinician to store and transport a wet fecal
sample from the patient to the central facility.
[0191] In Example 156, the providing the kit to the clinician of
any one or more of Examples 1-155 can optionally include providing
a kit enabling the clinician to store, freeze, and transport the
wet fecal sample from the patient to the central facility.
[0192] In Example 157, a system can include, or can optionally be
combined with any portion or combination of any portions of any one
or more of Examples 1-156 to include, subject matter that can
include means for performing any one or more of the functions of
Examples 1-156, or a machine-readable medium including instructions
that, when performed by a machine, cause the machine to perform any
one or more of the functions of Examples 1-156.
[0193] These non-limiting examples described above can be combined
in any permutation or combination.
[0194] The above detailed description includes references to the
accompanying drawings, which form a part of the detailed
description. The drawings show, by way of illustration, specific
embodiments in which the invention can be practiced. These
embodiments are also referred to herein as "examples." Such
examples can include elements in addition to those shown or
described. However, the present inventors also contemplate examples
in which only those elements shown or described are provided.
Moreover, the present inventors also contemplate examples using any
combination or permutation of those elements shown or described (or
one or more aspects thereof), either with respect to a particular
example (or one or more aspects thereof), or with respect to other
examples (or one or more aspects thereof) shown or described
herein.
[0195] All publications, patents, and patent documents referred to
in this document are incorporated by reference herein in their
entirety, as though individually incorporated by reference. In the
event of inconsistent usages between this document and those
documents so incorporated by reference, the usage in the
incorporated reference(s) should be considered supplementary to
that of this document; for irreconcilable inconsistencies, the
usage in this document controls.
[0196] In this document, the terms "a" or "an" are used, as is
common in patent documents, to include one or more than one,
independent of any other instances or usages of "at least one" or
"one or more." In this document, the term "or" is used to refer to
a nonexclusive or, such that "A or B" includes "A but not B," "B
but not A," and "A and B," unless otherwise indicated. In this
document, the terms "including" and "in which" are used as the
plain-English equivalents of the respective terms "comprising" and
"wherein." Also, in the following claims, the terms "including" and
"comprising" are open-ended, that is, a system, device, article, or
process that includes elements in addition to those listed after
such a term in a claim are still deemed to fall within the scope of
that claim. Moreover, in the following claims, the terms "first,"
"second," and "third," etc. are used merely as labels, and are not
intended to impose numerical requirements on their objects.
[0197] Method examples described herein can be machine or
computer-implemented at least in part. Some examples can include a
computer-readable medium or machine-readable medium encoded with
instructions operable to configure an electronic device to perform
methods as described in the above examples. An implementation of
such methods can include code, such as microcode, assembly language
code, a higher-level language code, or the like. Such code can
include computer readable instructions for performing various
methods. The code may form portions of computer program products.
Further, in an example, the code can be tangibly stored on one or
more volatile, non-transitory, or non-volatile tangible
computer-readable media, such as during execution or at other
times. Examples of these tangible computer-readable media can
include, but are not limited to, hard disks, removable magnetic
disks, removable optical disks (e.g., compact disks and digital
video disks), magnetic cassettes, memory cards or sticks, random
access memories (RAMs), read only memories (ROMs), and the
like.
[0198] The above description is intended to be illustrative, and
not restrictive. For example, the above-described examples (or one
or more aspects thereof) may be used in combination with each
other. Other embodiments can be used, such as by one of ordinary
skill in the art upon reviewing the above description. The Abstract
is provided to comply with 37 C.F.R. .sctn.1.72(b), to allow the
reader to quickly ascertain the nature of the technical disclosure.
It is submitted with the understanding that it will not be used to
interpret or limit the scope or meaning of the claims. Also, in the
above Detailed Description, various features may be grouped
together to streamline the disclosure. This should not be
interpreted as intending that an unclaimed disclosed feature is
essential to any claim. Rather, inventive subject matter may lie in
less than all features of a particular disclosed embodiment. Thus,
the following claims are hereby incorporated into the Detailed
Description, with each claim standing on its own as a separate
embodiment, and it is contemplated that such embodiments can be
combined with each other in various combinations or permutations.
The scope of the invention should be determined with reference to
the appended claims, along with the full scope of equivalents to
which such claims are entitled.
* * * * *