Compositions and methods for transplantation of colon microbiota
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.
1. An oral capsule comprising:
1) a composition comprising a fecal extract or preparation comprising a 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 fecal extract or preparation is capable of passing through a 0.5 mm sieve and further comprises a pharmaceutically acceptable carrier; 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 composition of claim 1 , wherein the composition comprises no greater than about 5% non-living fecal material relative to biological fecal material by weight.
3. The composition of claim 2 , wherein the composition comprises no greater than about 2.5% non-living fecal material relative to biological fecal material by weight.
4. The composition of claim 2 , wherein the composition comprises no greater than about 1% non-living fecal material relative to biological fecal material by weight.
5. The composition of claim 2 , wherein the composition comprises no greater than about 0.1% non-living material relative to biological fecal material by weight.
6. The composition of claim 1 , wherein the composition is frozen.
7. The composition of claim 1 , wherein the composition is a solid.
8. The composition of claim 1 , wherein the composition comprises at least 1×10 10 cells.
9. The composition of claim 1 , wherein the composition is for replacing microbiota of a patient having a disease characterized by dysfunctional microbiota.
10. The composition of claim 9 , wherein the disease is selected from the group consisting of a Clostridium difficile colitis, a metabolic syndrome, obesity, asthma, eczema, an eosinophilic disorder of the gastrointestinal tract, inflammatory bowel disease, irritable bowel syndrome, ulcerative colitis, Crohn's disease, enterohemorrhagic colitis, chronic diarrhea, chronic constipation, an eating disorder, malnutrition, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, fibromyalgia, chronic fatigue syndrome, and a neurodegenerative disorder.
11. The composition of claim 9 , wherein the disease is a recurrent Clostridium difficile infection.
12. The composition of claim 9 , wherein a single dosage of the composition comprises between 1×10 10 and 5×10 10 cells.
13. The composition of claim 9 , wherein a single dosage of the composition comprises about 3×10 10 cells.
14. The composition of claim 9 , wherein the disease is obesity.
15. The composition of claim 9 , wherein the disease is inflammatory bowel disease.
16. The composition of claim 9 , wherein the disease is irritable bowel syndrome.
17. The composition of claim 9 , wherein the disease is ulcerative colitis.
18. The composition of claim 9 , wherein the disease is Crohn's disease.
19. The composition of claim 9 , wherein the disease is enterohemorrhagic colitis.
20. The composition of claim 9 , wherein the disease is chronic diarrhea.
21. The composition of claim 9 , wherein the disease is chronic constipation.
22. The composition of claim 9 , wherein the disease is chronic fatigue syndrome.