Compositions for fecal floral transplantation and methods for making and using them and devices for delivering them
The present disclosure provides compositions, e.g., formulations, used for gastric, gastrointestinal and/or colonic treatments or lavage, e.g., orthostatic lavage, e.g., for inducing the purgation (e.g., cleansing) of a gastrointestinal (GI) tract, including a colon; and methods for using them. Methods of the invention are used for the stabilization, amelioration, treatment and/or prevention of constipation, for the treatment of abdominal pain, particularly non-specific abdominal pain, and diarrhea, including diarrhea caused by a drug side effect, a psychological condition, a disease or a condition such as Crohn's Disease, a poison, a toxin or an infection, e.g., a toxin-mediated traveler's diarrhea, or C. difficile or the pseudo-membranous colitis associated with this infection.
1. A method comprising: receiving a stool or portion thereof from a human donor, wherein the stool or portion thereof comprises a community of uncultured fecal bacteria; mixing the stool or portion thereof with a saline solution to form a mixture; processing the mixture to collect the community of uncultured fecal bacteria; and selectively removing bacterial species from the community of uncultured fecal bacteria to produce a composition comprising bacterial strains of the phylum Firmicutes , wherein the composition further comprises a cryoprotectant.
2. The method of claim 1 , wherein the cryoprotectant is added to the composition after the selectively removing step.
3. The method of claim 1 , wherein the selectively removing step comprises centrifugation.
4. The method of claim 1 , wherein the cryoprotectant is glycerol.
5. The method of claim 1 , wherein the composition does not include rough particulate matter from the stool or portion thereof.
6. The method of claim 1 , further comprising encapsulating the composition in an acid-resistant capsule.
7. The method of claim 6 , wherein the composition is formulated as a liquid.
8. The method of claim 1 , wherein the proportion of bacteria from the phylum Firmicutes relative to non- Firmicutes bacteria in the composition is greater than such proportion in the stool or portion thereof.
9. The method of claim 1 , wherein the composition comprises less than 1.0% fecal non-floral material from the stool of the donor.
10. The method of claim 1 , wherein the composition does not contain viable Bacteroides.
11. The method of claim 1 , further comprising encapsulating the composition for delivery to the small intestine.
12. The method of claim 1 , wherein processing the mixture comprises homogenizing and filtering the mixture.
13. A method comprising: receiving a stool or portion thereof from a healthy human donor, wherein the stool or portion thereof comprises a collection of uncultured fecal bacteria; mixing the stool or portion thereof with a saline solution to form a mixture; homogenizing and filtering the mixture to separate rough particulate matter from the collection of uncultured fecal bacteria; and selectively removing bacteria from the collection of uncultured fecal bacteria to produce a composition comprising bacterial species of the phylum Firmicutes.
14. The method of claim 13 , wherein the composition further comprises a cryoprotectant.
15. The method of claim 14 , wherein the cryoprotectant comprises glycerol.
16. The method of claim 13 , further comprising encapsulating the composition in an acid-resistant capsule.
17. The method of claim 16 , wherein the composition is formulated as a liquid.
18. The method of claim 13 , wherein the proportion of bacteria from the phylum Firmicutes relative to non- Firmicutes bacteria in the composition is greater than such proportion in the stool.
19. The method of claim 13 , wherein the composition comprises less than 1.0% fecal non-floral material from the stool of the donor.
20. The method of claim 13 , wherein the composition does not contain viable Bacteroides.
21. The method of claim 13 , wherein the selectively removing step comprises centrifugation.