US2016367607A1PendingUtilityA1
Bacteriotherapy for clostridium difficile colitis
Est. expiryFeb 1, 2030(~3.6 yrs left)· nominal 20-yr term from priority
Inventors:Edwin J. Hlavka
A61P 31/04A61P 1/00A61P 1/12C12N 1/04A61K 9/20G01N 2333/33C12N 1/20A61K 35/741G01N 2800/52G01N 33/56911A61K 35/74
64
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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.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
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.Cited by (0)
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