Patent Description:
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.

<NPL> describes the preparation of fecal samples for the treatment of Clostridium Difficile infection.

According to a first aspect of the invention there is provided a bacteriotherapy product comprising an oral tablet or ingestible capsule and a processed donor fecal sample, the processed donor fecal sample comprising:.

According to a second aspect of the present invention, there is provided a bacteriotherapy product comprising an ampule and a processed donor fecal sample, the processed donor fecal sample comprising:.

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.

It is not intended to provide an exclusive or exhaustive explanation of the disclosure.

The drawings illustrate generally, by way of example, but not by way of limitation, various examples discussed in the present document.

Each individual has a personalized gut microbiota including an estimated <NUM> to <NUM> or more species of bacertia, fungi, archaea and other microorganisms, up to <NUM> 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, antiobiotic-associated diarrhea (AAD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), obesity, among others.

Accordingly, the present disclosure provides, 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.

For example, estimates of clostridium difficile overpopulation incidence vary from <NUM> to <NUM> million occurrences in the United States per year, and are growing. In one estimate, hospital discharges with clostridium difficile doubled from <NUM> to <NUM>, with an estimated <NUM>% to <NUM>% compound annual growth rate. Current estimates indicate that patients affected by clostridium difficile overpopulation experience increased hospital stays from <NUM> to <NUM> days, with nearly <NUM>% of affected patients being readmitted within <NUM> 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 $<NUM> to $<NUM> billion annually. Moreover, an estimated <NUM> patient deaths per day are attributable to clostridium difficile overpopulation, a mortality rate of <NUM> to <NUM>%, and increasing.

Traditional treatment for clostridium difficile typically includes application antiobotics. Metronidazole ("Flagyl®") is the antibiotic of choice due to low price and high efficacy. However, for recurring cases (up to <NUM>% of total cases, for example, resistant to metronidazole), pregnant patients, or patients younger than <NUM> years of age, vancomycin ("Vancocin®") 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.

At first occurrence, antibiotic treatment for clostridium difficile can be acutely effective to treat diarrhea within <NUM> to <NUM> days at a rate approximately at or above <NUM>%. However, clostridium difficile typically recurs after the first occurrence (e.g., several days to <NUM> weeks after cessation of antibiotics) at an estimated <NUM>% rate (e.g., <NUM>%-<NUM>%). However, for each recurrence following the first recurrence, the rate increases greatly, to an estimated <NUM>% rate following the second recurrence, and to greater than an estimated <NUM>% rate or greater thereafter. It is estimated that approximately <NUM>% of patients have <NUM> or more recurrences.

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 <NUM>, three times daily ("TID") for <NUM> to <NUM> days). For a second recurrence, vancomycin can be administered orally in tapered or pulsed doses (e.g., at a dose of <NUM>, four times daily ("QID") for <NUM> days; at a dose of <NUM>, twice daily ("BID") for <NUM> days; at a dose of <NUM>, once daily ("QD") for <NUM> days; at a dose of <NUM>, once every <NUM> days for <NUM> days (four doses); at a dose of <NUM>, once every <NUM> days for <NUM> days (five doses), etc.). For a third recurrence, vancomycin can be applied at greater doses (e.g., at a dose of <NUM>, four times daily ("QID") for <NUM> days), combined with any of the other options for recurrent infection, such as intravenous immunoglobulin (e.g., at a dose of <NUM> 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 <NUM>, twice daily ("BID") for <NUM> days), etc..

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.

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.

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.).

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.

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-resitant 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.

<FIG> illustrates generally an example of a Treatment Model <NUM> including a <NUM> day fecal bacteriotherapy treatment cycle. At <NUM>, day <NUM>, 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 <NUM>, the occurrence of one or more undesirable conditions, such as obesity, etc., can be detected, triggering application of the Treatment Model <NUM>.

At <NUM>, day <NUM>, 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 <NUM>) four times daily for <NUM> days (QID x 4d). 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.).

At <NUM>, day <NUM>, 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.

At <NUM>, day <NUM>, the fecal sample can be taken from a proposed donor, from the patient, or from both the proposed donor and the patient. At <NUM>, day <NUM>, 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.

At <NUM>, day <NUM>, 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 <NUM>, day <NUM>, the fecal sample can be screened for parasites or other pathogens, prior to or after processing. At <NUM>, day <NUM>, the blood draw can be screened for communicable disease, to further ensure a healthy donor fecal sample.

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 <NUM>, day <NUM>, 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.

<FIG> illustrates generally an example of a bacteriotherapy bank <NUM> including a cooling device (e.g., a refrigerator <NUM>, etc.) having a plurality of shelves (e.g., such as a first shelf <NUM>, etc.) configured to store one or more processed and screened donor fecal samples. In an example, the bacteriotherapy bank <NUM> 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.

In an example, the bacteriotherapy bank <NUM> 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 <NUM>, or can be indexed using one or more other indexing operations.

In an example, using the bacteriotherapy bank <NUM>, 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..

In certain examples, the bacteriotherapy bank <NUM> can store material at temperatures of -<NUM> 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.

<FIG> illustrates generally an example of a method <NUM> of receiving and storing donor fecal samples. At <NUM>, a donor fecal sample is received. At <NUM>, 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 <NUM>, 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.

<FIG> illustrates generally an example of a method <NUM> of receiving, storing, and indexing donor fecal samples. At <NUM>, a plurality of donor fecal samples are received. At <NUM>, 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 <NUM>, 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 <NUM>, 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.

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 <NUM> 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.

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.

References to methods of treatment by therapy in this description are to be interpreted as references to compounds, pharmaceutical compositions and medicaments of the claims for use in those methods.

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.

A characteristic of the donor fecal sample of the method can optionally include a characteristic of the fecal biota of the donor fecal sample.

The characteristic of the donor fecal sample of the method can optionally include at least one of a physical characteristic or a dietary characteristic of the donor.

The physical characteristic of the donor of the methodcan 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.

The physical characteristic of the donor of the method 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.

The medical condition of the donor of the method can optionally include at least one of a metabolic disorder or a digestive disorder.

The metabolic disorder of the method can optionally include diabetes mellitus, and the digestive disorder of the method can optionally include a gastrointestinal (GI) disorder including at least one of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD).

The dietary characteristic of the donor of the method can optionally include at least one of a donor geographic consumption region, a donor diet, or a donor religion.

The receiving the plurality of donor fecal samples of the method can optionally include processing each of the plurality of donor fecal samples, including homogenizing and filtering each of the donor fecal samples.

The receiving the plurality of donor fecal samples of the method can optionally include receiving a plurality of donor fecal samples from a plurality of screened donors.

The method 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.

The method can optionally include providing the fecal dose to the patient to transfer a functioning biota in the patient.

The providing the fecal dose to the patient to transfer the functioning biota in the patient of the method can optionally include to treat at least one of antibiotic associated diarrhea or a Clostridium difficile infection.

The receiving the request for donor fecal matter of the method can optionally include receiving at least one desired characteristic.

The receiving the at least one desired characteristic of the method can optionally include receiving at least one of a desired physical characteristic or a desired dietary characteristic of the donor.

The storing at least a portion of each of the plurality of donor fecal samples of the method can optionally include storing at least a portion of each of the plurality of donor fecal samples in a patient-deliverable form.

The storing at least a portion of each of the plurality of donor fecal samples in the patient-deliverable form of the method 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.

The receiving the plurality of donor fecal samples of the method 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 the method 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 the method 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.

The method 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.

The method can optionally include preparing a fecal dose configured to be provided to a single patient using a plurality of donor fecal samples.

The preparing the fecal dose of the method 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.

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.

The characteristic of the donor fecal sample of the method or fecal bank can optionally include at least one of a physical characteristic or a dietary characteristic of the donor.

The characteristic of the donor fecal sample of the method or fecal bank can optionally include a characteristic of the fecal biota of the donor fecal sample.

The physical characteristic of the donor of the method or fecal bank 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.

The physical characteristic of the donor of the method or fecal bank 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.

The medical condition of the donor of the method or fecal bank 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).

The dietary characteristic of the donor of the method or fecal bank can optionally include at least one of a donor geographic consumption region, a donor diet, or a donor religion.

The plurality of donor fecal samples of the method or fecal bank 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.

The plurality of fecal storage containers of the method or fecal bank can optionally include a plurality of patient-deliverable fecal storage containers.

The plurality of patient-deliverable fecal storage containers of the method or fecal bank 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.

A system can include, or can optionally be combined with any portion or combination of any portions of the method or fecal bank to include, subject matter that can include means for performing any one or more of the functions of the method or fecal bank, 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 the method or fecal bank.

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.

The receiving the donor fecal sample from the donor of the methods or fecal bank can optionally include receiving a plurality of donor fecal samples from a plurality of donors, wherein the processing the donor fecal sample of the methods or fecal bank can optionally include processing each of the plurality of donor fecal samples, wherein the processing of the methods or fecal bank 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 the methods or fecal bank can optionally include storing at least a portion of each of the plurality of processed donor fecal samples.

The methods or fecal bank 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.

The characteristic of the donor fecal sample of the methods or fecal bank can optionally include a characteristic of the fecal biota of the donor fecal sample.

The characteristic of the donor fecal sample of the methods or fecal bank can optionally include at least one of a physical characteristic or a dietary characteristic of the donor.

The physical characteristic of the donor of the methods or fecal bank 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.

The physical characteristic of the donor of the methods or fecal bank can optionally include a medical condition of the donor, and wherein the characteristic of the donor fecal sample of the methods or fecal bank can optionally include the presence or absence of a medical condition of the donor.

The medical condition of the donor of the methods or fecal bank can optionally include at least one of a metabolic disorder or a digestive disorder, wherein the metabolic disorder can optionally include diabetes mellitus, and wherein the digestive disorder includes a gastrointestinal (GI) disorder , the disorder can optionally include at least one of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD).

The dietary characteristic of the donor of the methods or fecal bank can optionally include at least one of a donor geographic consumption region, a donor diet, or a donor religion.

The methods or fecal bank 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 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.

The methods or fecal bank can optionally include providing the fecal dose to the patient to transfer a functioning biota in the patient.

The providing the fecal dose to the patient to transfer the functioning biota in the patient of the methods or fecal bank can optionally include to treat at least one of antibiotic associated diarrhea or a Clostridium difficile infection.

The receiving the request for donor fecal matter of the methods or fecal bank can optionally include receiving at least one desired characteristic.

The receiving the at least one desired characteristic of the methods or fecal bank can optionally include receiving at least one of a desired physical characteristic or a desired dietary characteristic of the donor.

The methods or fecal bank can optionally include preparing a fecal dose configured to be provided to a single patient using a plurality of processed donor fecal samples.

The preparing the fecal dose of the methods or fecal bank 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.

The processing the donor fecal sample of the methods or fecal bank can optionally include filtering the donor fecal sample.

The receiving the donor fecal sample of the methods or fecal bank can optionally include receiving a donor fecal sample from a screened donor.

The storing at least a portion of the processed donor fecal sample of the methods or fecal bank can optionally include storing at least a portion of the processed donor fecal sample in a patient-deliverable form.

The storing at least a portion of the processed donor fecal sample in the patient-deliverable form of the methods or fecal bank 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.

The receiving the donor fecal sample of the methods or fecal bank can optionally include receiving a wet fecal sample, wherein the processing the donor fecal sample 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 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.

The adding the cryoprotectant of the methods or fecal bank can optionally include at least one of glycol, glycerol, dimethyl sulfoxide (DMSO), dairy milk, or soy milk.

The methods or fecal bank 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.

At least a portion of the stored donor fecal sample of the methods or fecal bank 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.

The condition of the methods or fecal bank can optionally include at least one of a disease or an infection of or in the patient.

The condition of the methods or fecal bank can optionally include at least one of antibiotic associated diarrhea of the patient or a Clostridium difficile infection in the patient.

A system can include, or can optionally be combined with any portion or combination of any portions of the methods or fecal bank to include, subject matter that can include means for performing any one or more of the functions of the methods or fecal bank, 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 the methods or fecal bank.

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.

The receiving the donor fecal sample of the methods or fecal bank 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 form can optionally include storing at least a portion of each of the plurality of processed donor fecal samples in a patient-deliverable form.

The methods or fecal bank 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.

The physical characteristic of the donor of the methods or fecal bank can optionally include a medical condition of the donor and wherein the characteristic of the donor fecal sample can optionally include the presence or absence of a medical condition of the donor.

The medical condition of the donor of the methods or fecal bank can optionally include at least one of a metabolic disorder or a digestive disorder, wherein the metabolic disorder can optionally include diabetes mellitus, and wherein the digestive disorder can optionally include a gastrointestinal (GI) disorder including at least one of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD).

The methods or fecal bank 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.

The methods or fecal bank 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 can optionally include storing at least a portion of the processed donor fecal sample.

The storing at least a portion of the donor fecal sample in the patient-deliverable form of the methods or fecal bank 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.

The storing at least a portion of the donor fecal sample in the ingestible capsule of the methods or fecal bank can optionally include storing at least a portion of the donor fecal sample in a gastro-resistant capsule.

The methods or fecal bank 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.

The methods or fecal bank 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.

The physical characteristic of the donor of the methods or fecal bank can optionally include a medical condition of the donor, wherein the characteristic of the donor fecal sample can optionally include the presence or absence of a medical condition of the donor.

The processed donor fecal sample of the methods or fecal bank can optionally include a wet fecal sample, and wherein the patient-deliverable fecal storage container 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.

The patient-deliverable fecal storage container of the methods or fecal bank 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 retrograde GI delivery approach to the intestinal tract of the patient.

The condition of the patient of the methods or fecal bank can optionally include at least one of a disease or an infection of or in the patient.

The condition of the patient of the methods or fecal bank can optionally include at least one of antibiotic associated diarrhea of the patient or a Clostridium difficile infection in the patient.

A system can include, or can optionally be combined with any portion or combination of any portions of the methods or fecal bank to include, subject matter that can include means for performing any one or more of the functions of the methods or fecal bank, 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 the methods or fecal bank.

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.

The condition of the patient of the methods or fecal bank can optionally include a patient weight above a desired target weight.

The condition of the patient of the methods or fecal bank can optionally include obesity.

The characteristic of the donor of the methods or fecal bank can optionally include at least one of a physical characteristic or a dietary characteristic of the donor.

The physical characteristic of the donor of the methods or fecal bank 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.

The physical characteristic of the donor of the methods or fecal bank can optionally include a medical condition of the donor, and wherein the characteristic of the donor fecal sample can optionally include the presence or absence of a medical condition of the donor.

The methods or fecal bank can optionally include providing information about the dietary characteristic of the donor to the patient, wherein the dietary characteristic includes a donor diet.

The characteristic of the donor of the methods or fecal bank can optionally include the physical characteristic of the donor and the dietary characteristic of the donor.

The fecal dose of the methods or fecal bank 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 can optionally include using at least one characteristic of the plurality of donors.

The methods or fecal bank can optionally include receiving the donor fecal sample from the donor, processing the donor fecal sample, wherein the processing of the methods or fecal bank can optionally include homogenizing the donor fecal sample, and wherein the fecal dose of the methods or fecal bank can optionally include at least a portion of the processed donor fecal sample.

The receiving the donor fecal sample from the donor of the methods or fecal bank can optionally include receiving a plurality of donor fecal samples from a plurality of donors, wherein the processing the donor fecal sample of the methods or fecal bank can optionally include processing each of the plurality of donor fecal samples, wherein the processing 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.

The fecal dose of the methods or fecal bank 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.

The receiving the donor fecal sample of the methods or fecal bank 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 the methods or fecal bank 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.

The methods or fecal bank 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 can optionally include selecting at least one stored donor fecal sample.

The methods or fecal bank 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.

The methods or fecal bank 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 the methods or fecal bank 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 the methods or fecal bank 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.

The fecal dose of the methods or fecal bank 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 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.

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.

The methods or fecal bank 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.

The medical condition of the donor of the methods or fecal bank can optionally include at least one of a metabolic disorder or a digestive disorder.

The metabolic disorder of the methods or fecal bank can optionally include diabetes mellitus, and wherein the digestive disorder of the methods or fecal bank can optionally include a gastrointestinal (GI) disorder including at least one of irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD).

The providing the kit to the clinician of the methods or fecal bank 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 the methods or fecal bank can optionally include receiving a plurality of frozen donor fecal samples from one or more clinicians, wherein the screening the donor fecal sample of the methods or fecal bank can optionally include screening a plurality of donor fecal samples,
wherein the receiving the characteristic of the donor fecal sample of the methods or fecal bank 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 the methods or fecal bank can optionally include storing at least a portion of the plurality of donor fecal samples, and wherein the indexing the donor fecal sample of the methods or fecal bank can optionally include indexing each the plurality of donor fecal samples using a characteristic of the respective donor fecal sample.

The methods or fecal bank 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.

The storing at least a portion the donor fecal sample of the methods or fecal bank can optionally include storing at least a portion of the donor fecal sample in a patient-deliverable form.

The storing at least a portion of the donor fecal sample in a patient-deliverable form of the methods or fecal bank 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.

The methods or fecal bank can optionally include processing the donor fecal sample, the processing the donor fecal sample can optionally include homogenizing and filtering the donor fecal sample.

The processing the donor fecal sample of the methods or fecal bank 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 the methods or fecal bank can optionally include freezing the donor fecal sample to maintain viability of the biota of the donor fecal sample.

The methods or fecal bank 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.

The providing the kit to the clinician of the methods or fecal bank can optionally include providing a kit enabling the clinician to store and transport a wet fecal sample from the patient to the central facility.

The providing the kit to the clinician of the methods or fecal bank 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.

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 the methods or fecal bank can optionally include at least a portion of at least one donor fecal sample.

The methods or fecal bank 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.

The methods or fecal bank 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.

The providing the fecal dose to the clinician of the methods or fecal bank 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.

The providing the kit to the clinician of the methods or fecal bank can optionally include providing a sterile kit to the clinician.

The providing the kit to the clinician and the providing the fecal dose to the clinician of the methods or fecal bank can optionally include using expedited shipping.

The expedited shipping of the methods or fecal bank can optionally include overnight shipping.

The methods or fecal bank 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.

The methods or fecal bank 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.

The drawings show, by way of illustration, specific examples in which the disclosure can be practiced. Such examples can include elements in addition to those shown or described.

" 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.

Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or nonvolatile tangible computer-readable media, such as during execution or at other times.

Claim 1:
A bacteriotherapy product comprising an oral tablet or ingestible capsule and a processed donor faecal sample, the processed donor faecal sample comprising:
a donor faecal sample;
a cryoprotectant added to the donor faecal sample; and
wherein the donor faecal sample is homogenized and filtered to form the processed donor faecal sample and wherein the processed donor faecal sample is disposed within the oral tablet or the ingestible capsule.