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; and methods for making and 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 pharmaceutical composition comprising saline, a cryoprotectant and a microbiota of a stool sample comprising anaerobic bacteria, wherein particular bacterial species have not been pre-segregated from the microbiota, wherein the pharmaceutical composition is formulated for administration to a subject by enema through flexible tubing, wherein the pharmaceutical composition is contained in a container configured to provide a reduced oxygen environment to preserve the anaerobic bacteria.
2. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises no more than 1% rough particulate matter of the stool sample.
3. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises no more than 0.8% rough particulate matter of the stool sample.
4. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises no more than 0.5% rough particulate matter of the stool sample.
5. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises no more than 0.3% rough particulate matter of the stool sample.
6. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises no rough particulate matter of the stool sample.
7. The pharmaceutical composition of claim 1 , wherein the container comprises an oxygen-resistant material.
8. The pharmaceutical composition of claim 1 , wherein the container is sealed.
9. The pharmaceutical composition of claim 8 , wherein the container is configured for shipping to a remote facility as part of an enema delivery system, wherein the enema delivery system further comprises the flexible tubing.
10. The pharmaceutical composition of claim 1 , wherein the container comprises a polymer.
11. The pharmaceutical composition of claim 10 , wherein the polymer is ethylene.
12. The pharmaceutical composition of claim 1 , wherein the container is a bag.
13. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is administered to the subject in an amount effective for treating recurrence of C. difficile infection.
14. The pharmaceutical composition of claim 1 , wherein the cryoprotectant comprises polyethylene glycol.
15. The pharmaceutical composition of claim 1 , wherein the stool sample is derived from a healthy human donor.
16. The pharmaceutical composition of claim 1 , wherein the stool sample has a weight of 50 grams.
17. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is frozen.
18. The pharmaceutical composition of claim 1 , wherein the saline comprises sodium chloride.
19. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further comprises an antioxidant.