IP Library Granted Patent US 11,986,500
Granted Patent B2
US 11,986,500 · App. 18/544,083 · Granted May 21, 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 11,986,500
App. No.
18/544,083
Granted
May 21, 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 (26)

1. A fecal microbiota composition, comprising:

a processed fecal sample obtained from a human donor, and

a cryoprotectant.

2. The composition of claim 1 , wherein the cryoprotectant comprises one or more selected from a glycol, glycerol, dimethyl sulfoxide, dairy milk, and soy milk.

3. The composition of claim 1 , wherein the cryoprotectant comprises glycerol.

4. A method of treating a gastrointestinal disorder, comprising administering a composition according to claim 1 to a subject in need thereof.

5. The method of claim 4 , wherein the cryoprotectant comprises glycerol.

6. The method of claim 4 , wherein the method comprises administering the composition by nasogastric delivery.

7. The method of claim 4 , wherein the method comprises administering the composition by enema.

8. The method of claim 4 , wherein the method comprises administering the composition by colonoscopy.

9. The method of claim 4 , wherein the composition is comprised in an oral tablet, and the method comprises orally administering the tablet.

10. The method of claim 4 , wherein the composition is comprised in an oral capsule, and the method comprises orally administering the capsule.

11. The method of claim 4 , wherein the subject has or previously has had a Clostridium difficile ( C. difficle ) infection.

12. The method of claim 4 , wherein the subject has previously been treated for a C. difficle infection.

13. A fecal microbiota transplantation method, comprising administering a composition according to claim 1 to a subject in need thereof.

14. The method of claim 13 , wherein the cryoprotectant comprises glycerol.

15. The method of claim 13 , wherein the method comprises administering the composition by nasogastric delivery.

16. The method of claim 13 , wherein the method comprises administering the composition by enema.

17. The method of claim 13 , wherein the method comprises administering the composition by colonoscopy.

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 a C. difficle infection.

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

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

23. The method of claim 21 , wherein the subject has or previously has had a C. difficle infection.

24. The method of claim 21 , wherein the subject has previously been treated for a C. difficle infection.

Assignments (4)
CORRECTIVE ASSIGNMENT TO CORRECT THE INVENTOR EDWIN J. HLAVKA'S EXECUTION DATE FROM 03/13/2023 TO 03/13/2013 PREVIOUSLY RECORDED ON REEL 66407 FRAME 291. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jun 11, 2025
From: HLAVKA, EDWIN J.
To: MIKROBEX INC.
Reel/Frame 071514/0240 →
CHANGE OF NAME Recorded Jan 27, 2025
From: REBIOTIX INC.
To: FERRING MICROBIOME INC.
Reel/Frame 070022/0505 →
CHANGE OF NAME Recorded Feb 8, 2024
From: MIKROBEX INC.
To: REBIOTIX INC.
Reel/Frame 066541/0094 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 7, 2024
From: HLAVKA, EDWIN J.
To: MIKROBEX INC.
Reel/Frame 066407/0291 →
Continuity (8)
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 20240122995A1 · Apr 18, 2024
Cited By (1)
US 12,303,537