Compositions and methods
Provided are defined bacterial compositions for the maintenance or restoration of a healthy microbiota in the gastrointestinal tract of a mammalian subject, and methods for populating the gastrointestinal tract of a subject. Provided also are bacterial formulations for oral or gastric administration to a mammalian subject in an effective amount for prevention or treatment of a gastrointestinal disease, disorder or condition.
1. A composition consisting essentially of:
a bacterial population consisting of from seven to nine purified bacterial strains, wherein two of the bacterial strains are Clostridium innocuuin and Blautia producta ; and
a capsule substantially encapsulating the bacterial population;
wherein the bacterial strains are present in the composition in an amount effective to treat a C. difficile infection in a mammalian subject.
2. The composition of claim 1 , wherein each bacterial strain is purified by selecting its colony from a plate of single colonies and re-streaking the colony on solid media at least three times.
3. The composition of claim 2 , wherein at least three of the bacterial strains are not present in the composition in equal ratios.
4. The composition of claim 2 , wherein at least one of the bacterial strains is provided in a concentration of greater than 1)(10 9 viable bacteria per gram of the composition.
5. The composition of claim 2 , wherein the bacterial strains are present at a concentration of at least 1×10 4 viable bacteria.
6. The composition of claim 1 , wherein the bacterial strains are substantially encapsulated in an enteric coating.
7. The composition of claim 1 , wherein upon oral administration to a mammal having a C. difficile infection, the composition reduces C. difficile associated weight loss compared to a control composition not containing the bacterial strains.
8. The composition of claim 1 , wherein upon oral administration to a mammal having a C. difficile infection, the composition reduces C. difficile associated mortality compared to a control composition not containing the bacterial strains.
9. The composition of claim 1 , wherein upon oral administration to a mammal having a C. difficile infection, the composition improves the clinical score compared to a mammal not receiving administration of the composition.
10. The composition of claim 1 , wherein the composition has a mortality score of equal to or less than 1.5 when tested in a mouse model.
11. The composition of claim 1 , wherein the composition as a mortality score of equal to or less than 1 when tested in a mouse model.
12. The composition of claim 1 , wherein the composition has a weight score of equal to or less than 1.5 when tested in a mouse model.
13. The composition of claim 1 , wherein the composition has a weight score of equal to or less than 1 when tested in a mouse model.
14. The composition of claim 2 , wherein the composition has a summary score of a mortality score, a weight score, and a clinical score of equal to or less than 4 when tested in a mouse model.
15. The composition of claim 2 , wherein the composition has a summary score of a mortality score, a weight score, and a clinical score of equal to or less than 2 when tested in a mouse model.
16. The composition of claim 2 , wherein the bacterial population consists of seven purified bacterial strains.
17. The composition of claim 2 , wherein the bacterial population consists of eight purified bacterial strains.
18. The composition of claim 2 , wherein the bacterial population consists of nine purified bacterial strains.
19. The composition of claim 2 , further consisting essentially of an excipient.