IP Library Granted Patent US 12,303,537
Granted Patent B2
US 12,303,537 · App. 18/820,753 · Granted May 20, 2025

Bacteriotherapy for clostridium difficile colitis

Inventor: Edwin J. Hlavka (Minneapolis, MN)
Assignee: Ferring Microbiome Inc.
A61K35/741A61K9/20A61K35/74C12N1/04C12N1/20G01N33/56911G01N2333/33G01N2800/52
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Quick Facts
Patent No.
US 12,303,537
App. No.
18/820,753
Granted
May 20, 2025
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 (24)

1. An oral composition, comprising:

a processed fecal sample obtained from a human donor; and

glycerol.

2. The composition of claim 1 , wherein the processed fecal sample has been prepared by a process comprising screening for pathogens.

3. The composition of claim 1 , wherein the processed fecal sample has been prepared by a process comprising filtration.

4. The composition of claim 1 , wherein the composition is comprised in an oral capsule.

5. A method of reducing the risk of a recurrent Clostridium difficile infection, comprising orally administering an oral capsule containing a composition comprising a processed fecal sample obtained from a human donor and glycerol to a subject in need thereof.

6. The method of claim 5 , wherein the processed fecal sample has been screened for pathogens.

7. The method of claim 5 , wherein the patient has been treated with an antibiotic prior to the administration.

8. The method of claim 5 , wherein the subject has or previously has had a C. difficle infection.

9. The method of claim 5 , wherein the subject has previously been treated for C. difficle infection.

10. A fecal microbiota composition, comprising:

a processed fecal sample obtained from a human donor;

and an effective amount of a cryoprotectant.

11. The composition of claim 10 , wherein the cryoprotectant comprises one or more selected from a glycol, glycerol, dimethyl sulfoxide, dairy milk, and soy milk.

12. The composition of claim 10 , wherein the cryoprotectant comprises glycerol.

13. A method of treating a gastrointestinal disorder, comprising administering a composition according to claim 10 to a subject in need thereof.

14. The method of claim 13 , wherein the composition has been processed for nasogastric delivery, and the method comprises administering the composition by nasogastric delivery.

15. The method of claim 13 , wherein the composition has been processed for delivery by enema, and the method comprises administering the composition by enema.

16. The method of claim 13 , wherein the composition has been processed for delivery by colonoscopy, and the method comprises administering the composition by colonoscopy.

17. The method of claim 13 , wherein the composition is comprised in an oral tablet, and the method comprises orally administering the tablet.

18. The method of claim 13 , wherein the composition is comprised in an oral capsule, and the method comprises orally administering the capsule.

19. The method of claim 13 , wherein the subject has or previously has had a C. difficle infection.

20. The method of claim 13 , wherein the subject has previously been treated for C. difficle infection.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 22, 2025
From: HLAVKA, EDWIN J.
To: MIKROBEX, INC.
Reel/Frame 070914/0164 →
CHANGE OF NAME Recorded Apr 22, 2025
From: MIKROBEX INC.
To: REBIOTIX, INC.
Reel/Frame 070946/0535 →
CHANGE OF NAME Recorded Apr 22, 2025
From: REBIOTIX INC.
To: FERRING MICROBIOME INC.
Reel/Frame 070947/0158 →
Continuity (10)
Continuation 18631959 · Apr 10, 2024
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 20240415899A1 · Dec 19, 2024
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