Compositions and methods for transplantation of colon microbiota

Patent metadata

Field	Value
Publication number	US-9968638-B2
Application number	US-201214003411-A
Country	US
Kind code	B2
Filing date	Mar 9, 2012
Priority date	Mar 9, 2011
Publication date	May 15, 2018
Grant date	May 15, 2018

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.

First claim

What is claimed is:

1. A substantially odorless oral capsule comprising:
(1) a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a human fecal extract comprising a human fecal donor's intestinal microbiota comprising at least 5 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 non-living material and particles of biological material, and said human fecal extract comprises no particle having a size of greater than 0.5 mm; and
(2) at least one ingredient selected from the group consisting of a gelling agent, a plant polysaccharide or derivative thereof, a disintegrating agent, a lubricant, a glidant, a sweetening agent, a plasticizer, a surface treatment agent, a coloring agent, a preservative, and a flavoring agent.

2. The oral capsule of claim 1 , wherein said capsule is resistant to high acidity in the stomach, intestinal digestive enzymes, or both.

3. The oral capsule of claim 1 , wherein said pharmaceutical composition further comprises a cryoprotectant.

4. The oral capsule of claim 3 , wherein said cryoprotectant is selected from the group consisting of trehalose, alanine, glycine, proline, sucrose, glucose, lactose, ribose, dimethyl sulfoxide (DMSO), and glycerol.

5. The oral capsule of claim 1 , wherein said pharmaceutical composition is frozen.

6. The oral capsule of claim 1 , wherein said pharmaceutical composition is freeze-dried.

7. The oral capsule of claim 1 , wherein said pharmaceutical composition is a solid.

8. The oral capsule of claim 7 , wherein said solid comprises a powder.

9. The oral capsule of claim 1 , wherein said pharmaceutical composition comprises at least 1×10 10 cells.

10. The oral capsule of claim 1 , wherein said human fecal extract comprises biological material representative of the biological material of fresh feces from a normal healthy human.

11. The oral capsule of claim 1 , wherein said pharmaceutical composition is capable of restoring a normal intestinal microbiota in a patient having one or more diseases selected from the group consisting of Clostridium difficile colitis, inflammatory bowel disease, ulcerative colitis, Crohn's disease, irritable bowel syndrome, enterohemorrhagic colitis, chronic diarrhea, chronic constipation, asthma, eczema, rheumatoid arthritis, systemic lupus erythematosis, multiple sclerosis, fibromyalgia, chronic fatigue syndrome, neurodegenerative disorders, eating disorders, and malnutrition.

12. The oral capsule of claim 1 , wherein said pharmaceutical composition is effective for treating a Clostridium difficile infection.

13. The oral capsule of claim 1 , wherein said pharmaceutical composition is capable of increasing bacterial species diversity of a patient's gut, colon or intestinal flora.

14. The oral capsule of claim 6 , wherein said pharmaceutical composition is capable of restoring a normal intestinal microbiota in a patient having one or more diseases selected from the group consisting of Clostridium difficile colitis, inflammatory bowel disease, ulcerative colitis, Crohn's disease, irritable bowel syndrome, enterohemorrhagic colitis, chronic diarrhea, chronic constipation, asthma, eczema, rheumatoid arthritis, systemic lupus erythematosis, multiple sclerosis, fibromyalgia, chronic fatigue syndrome, neurodegenerative disorders, eating disorders, and malnutrition.

15. The oral capsule of claim 1 , said human fecal extract comprises no particle having a size of greater than 0.25 mm.

16. The oral capsule of claim 1 , wherein said pharmaceutical composition is capable of restoring a normal intestinal microbiota in a patient having inflammatory bowel disease.

17. The oral capsule of claim 1 , wherein said pharmaceutical composition is capable of restoring a normal intestinal microbiota in a patient having ulcerative colitis.

18. The oral capsule of claim 1 , wherein said pharmaceutical composition is capable of restoring a normal intestinal microbiota in a patient having Crohn's disease.

19. The oral capsule of claim 1 , wherein said pharmaceutical composition is capable of restoring a normal intestinal microbiota in a patient having irritable bowel syndrome.

20. The oral capsule of claim 1 , wherein said pharmaceutical composition is capable of restoring a normal intestinal microbiota in a patient having enterohemorrhagic colitis.

21. The oral capsule of claim 1 , wherein said pharmaceutical composition is capable of restoring a normal intestinal microbiota in a patient having chronic diarrhea.

22. The oral capsule of claim 1 , wherein said pharmaceutical composition is capable of restoring a normal intestinal microbiota in a patient having chronic constipation.

23. The oral capsule of claim 1 , wherein said pharmaceutical composition is capable of restoring a normal intestinal microbiota in a patient having fibromyalgia chronic fatigue syndrome.

24. The oral capsule of claim 1 , wherein said pharmaceutical composition is capable of restoring a normal intestinal microbiota in a patient having chronic fatigue syndrome.

25. The oral capsule of claim 1 , wherein said pharmaceutical composition is effective for treating a recurrent Clostridium difficile infection.

Assignees

• Sadowsky Michael J
• Khoruts Alexander
• Weingarden Alexa R
• Hamilton Matthew J
• Univ Minnesota

Inventors

• Sadowsky Michael J
• Khoruts Alexander
• Weingarden Alexa R
• Hamilton Matthew J

Classifications

• A61P31/04

  Antibacterial agents · CPC title

• A61P1/00

  Drugs for disorders of the alimentary tract or the digestive system · CPC title

• A61P1/04

  for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants · CPC title

• A61P1/12

  Antidiarrhoeals · CPC title

• A61P1/10

  Laxatives · CPC title