IP Library Granted Patent US 12,102,655
Granted Patent B2
US 12,102,655 · App. 18/631,959 · Granted Oct 1, 2024

Bacteriotherapy for clostridium difficile colitis

Inventor: Edwin J. Hlavka (Minneapolis, MN)
Assignee: Rebiotix Inc.
A61K35/741A61K9/20A61K35/74C12N1/04C12N1/20G01N33/56911G01N2333/33G01N2800/52
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Quick Facts
Patent No.
US 12,102,655
App. No.
18/631,959
Granted
Oct 1, 2024
Kind
B2
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 (36)

1. A method of preparing a fecal microbiota composition, comprising:

receiving at a central processing facility a fecal sample obtained from a human donor;

screening the fecal sample for pathogens;

processing the fecal sample at the central processing facility to obtain a fecal microbiota composition comprising a homogenized and filtered fecal sample comprising fecal microbiota and a cryoprotectant; and

filling the fecal microbiota composition into a container.

2. The method of claim 1 , wherein the cryoprotectant comprises glycerol.

3. The method of claim 1 , wherein the container is labeled with or indexed to donor information.

4. The method of claim 1 , wherein the container is an enema bag.

5. The method of claim 1 , wherein the container is an oral capsule.

6. The method of claim 1 , further comprising providing the fecal microbiota composition to a clinician or patient for administration to a patient in need thereof.

7. The method of claim 1 , further comprising freezing the fecal microbiota composition to obtain a frozen fecal microbiota composition.

8. The method of claim 7 , further comprising storing the frozen fecal microbiota composition.

9. The method of claim 8 , further comprising:

receiving a request for a fecal microbiota composition to be administered to a patient in need thereof; and

selecting the frozen fecal microbiota composition to fulfill the request.

10. A method of preparing a plurality of fecal microbiota compositions, comprising:

(a) receiving at a central processing facility a fecal sample obtained from a human donor;

(b) screening the fecal sample for pathogens;

(c) processing the fecal sample at the central processing facility to obtain a fecal microbiota composition comprising a homogenized and filtered fecal sample comprising fecal microbiota and a cryoprotectant;

(d) filling the fecal microbiota composition into a container; and

(e) repeating steps (a)-(d) to obtain a plurality of fecal microbiota compositions in separate containers.

11. The method of claim 10 , further comprising freezing the fecal microbiota compositions to obtain a plurality of frozen fecal microbiota compositions in separate containers.

12. The method of claim 11 , further comprising storing the plurality of frozen fecal microbiota compositions in separate containers.

13. The method of claim 12 , further comprising:

receiving a request for a fecal microbiota composition to be administered to a patient in need thereof and

selecting a frozen fecal microbiota composition from the plurality of fecal microbiota compositions to fulfill the request.

14. The method of claim 10 , wherein each fecal sample is obtained from a single human donor and each container is labeled with or indexed to donor information.

15. The method of claim 10 , wherein the cryoprotectant comprises glycerol.

16. A fecal microbiota transplantation method comprising administering a composition prepared by a process according to claim 1 to a patient.

17. The method of claim 16 , wherein the method comprises administering the composition by enema.

18. The method of claim 16 , wherein the method comprises administering the composition by nasogastric delivery.

19. The method of claim 16 , wherein the method comprises administering the composition by colonoscopy.

20. The method of claim 16 , wherein the composition is comprised in an oral capsule, and the method comprises orally administering the capsule.

21. A method of reducing the risk of a recurrent Clostridium difficile infection, comprising administering a fecal microbiota composition prepared by a process according to claim 1 to a patient in need thereof.

22. The method of claim 21 , wherein the patient has previously been treated for a C. difficile infection.

23. The method of claim 21 , wherein the patient has been treated with an antibiotic prior to the administration.

Assignments (3)
CHANGE OF NAME Recorded Jan 27, 2025
From: REBIOTIX INC.
To: FERRING MICROBIOME INC.
Reel/Frame 070022/0505 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2024
From: HLAVKA, EDWIN J.
To: MIKROBEX INC.
Reel/Frame 067066/0683 →
CHANGE OF NAME Recorded Apr 10, 2024
From: MIKROBEX INC.
To: REBIOTIX INC.
Reel/Frame 067070/0265 →
Continuity (9)
Continuation 18544083 · Dec 18, 2023
Continuation 17886274 · Aug 11, 2022
Continuation 15964228 · Apr 27, 2018
Continuation 15251725 · Aug 30, 2016
Continuation 14093913 · Dec 2, 2013
Continuation 13576573
Provisional Application 61351184 · Jun 3, 2010
Provisional Application 61337283 · Feb 1, 2010
Related Publication 20240252556A1 · Aug 1, 2024