IP Library Granted Patent US 10,286,012
Granted Patent B2
US 10,286,012 · App. 15/594,319 · Granted May 14, 2019

Compositions and methods for transplantation of colon microbiota

Inventors: Michael J. Sadowsky (Roseville, MN); Alexander Khoruts (Golden Valley, MN); Alexa R. Weingarden (St. Paul, MN); Matthew J. Hamilton (Burnsville, MN)
Assignee: Regents of the University of Minnesota
A61K35/37A61K9/0053A61K9/16A61K9/1617A61K9/1623A61K35/24A61K35/74A61K35/741A61K35/742A61K45/06A61K47/08A61K47/26A61K2035/11Y02A50/473Y02A50/475
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,286,012
App. No.
15/594,319
Granted
May 14, 2019
Kind
B2
Abstract

The present invention provides compositions that include an extract of human feces, and methods for using such compositions, including methods for replacing or supplementing or modifying a subject's colon microbiota, and methods for treating a disease, pathological condition, and/or iatrogenic condition of the colon.

Claims (23)

1. A method of increasing the relative abundance of one or more members of the phylum Firmicutes in a patient in need thereof, the method comprising:

administering to said patient an effective amount of a pharmaceutical composition comprising a human fecal microbe preparation comprising a pharmaceutically acceptable carrier and a human fecal extract comprising a healthy human fecal donor's intestinal microbiota comprising at least 6 different classes of bacteria selected from the group consisting of Actinobacteria, Bacteroidia, Bacilli, Clostridia, Erysipelotrichi, Alphaproteobacteria, Betaproteobacteria, Gammaproteobacteria, Mollicutes, and Verrucomicrobiae,

wherein said human fecal extract comprises particles of nonliving material and particles of biological material, and said human fecal extract comprises no particle having a size of greater than 0.5 mm, and

wherein the administering increases the relative abundance of total members of the phylum Firmicutes by at least 20% compared to before said administering.

2. The method of claim 1 , wherein said administering increases the relative abundance of one or more members of the phylum Firmicutes by at least 20% compared to before said administering.

3. The method of claim 2 , wherein said one or more members of the phylum Firmicutes are one or more non-pathogenic members of the class Clostridia.

4. The method of claim 3 , wherein the relative abundance of said one or more non-pathogenic members of the class Clostridia is increased by at least 20% compared to before said administering.

5. The method of claim 1 , wherein the relative abundance is determined at a time selected from the group consisting of 3 days after said administering, 10 days after said administering, 15 days after said administering, and 25 days after said administering.

6. The method of claim 1 , wherein said administering is orally administering.

7. The method of claim 1 , further comprising pretreating said patient with one or more antibiotics prior to said administering.

8. The method of claim 7 , wherein said one or more antibiotics are selected from the group consisting of Metronidazole, Rifaximin, Vancomycin, and Neomycin.

9. The method of claim 1 , wherein said human fecal donor is unrelated to said patient.

10. The method of claim 1 , wherein said human fecal preparation consists essentially of particles capable of passing through a 0.5 mm sieve and the human fecal donor's intestinal microbiota.

11. The method of claim 1 , wherein said pharmaceutical composition is frozen.

12. The method of claim 1 , wherein said effective amount of said pharmaceutical composition comprises at least 5×10 10 cells.

13. The method of claim 1 , wherein said patient has a Clostridium difficile infection.

14. The method of claim 13 , wherein said administering also increases the fecal microbiota diversity in said patient compared to before said administering.

15. The method of claim 1 , wherein said patient has a recurrent Clostridium difficile infection.

16. The method of claim 1 , wherein said patient is at risk of developing a recurrent Clostridium difficile infection.

17. The method of claim 1 , wherein said patient has an inflammatory bowel disease.

18. The method of claim 1 , wherein said pharmaceutical composition is contained within a capsule.

19. The method of claim 1 , wherein said administering is rectally administering.

20. The method of claim 1 , wherein said pharmaceutical composition is lyophilized.

Assignments (2)
CONFIRMATORY LICENSE Recorded Sep 25, 2017
From: UNIVERSITY OF MINNESOTA
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 043987/0498 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 18, 2017
From: SADOWSKY, MICHAEL J; KHORUTS, ALEXANDER; WEINGARDEN, ALEXA R; HAMILTON, MATTHEW J
To: REGENTS OF THE UNIVERSITY OF MINNESOTA
Reel/Frame 042422/0083 →
Continuity (7)
Continuation 15261319 · Sep 9, 2016
Continuation 14003411
Continuation 15594319
Continuation 15173134 · Jun 3, 2016
Continuation 14003411
Provisional Application 61450838 · Mar 9, 2011
Related Publication 20170246214A1 · Aug 31, 2017
Cited By (1)
US 12,290,538