Microbiota restoration therapy (MRT), compositions and methods of manufacture
Microbiota restoration therapy compositions and methods for manufacturing, processing, and/or delivering microbiota restoration therapy compositions are disclosed. An example method for manufacturing a microbiota restoration therapy composition may include collecting a human fecal sample and adding a diluent to the human fecal sample to form a diluted sample. The diluent may include a cryoprotectant. The method may also include mixing the diluted sample with a mixing apparatus and filtering the diluted sample. Filtering may form a filtrate. The method may also include transferring the filtrate to a sample bag and sealing the sample bag.
1. A method for treating dysbiosis, the method comprising:
administering a microbiota restoration therapy composition to a patient with dysbiosis; and
wherein the microbiota restoration therapy composition is manufactured by:
collecting a fresh human fecal sample, and
adding a diluent to the fresh human fecal sample, the diluent including 30-90 g/L polyethylene glycol in saline.
2. The method of claim 1 , wherein administering the microbiota restoration therapy composition to the patient with dysbiosis includes administering the microbiota restoration therapy via an enema tube.
3. The method of claim 1 , wherein administering the microbiota restoration therapy composition to the patient with dysbiosis includes administering the microbiota restoration therapy composition orally.
4. The method of claim 1 , wherein the microbiota restoration therapy is characterized for genetic biodiversity prior to administering the microbiota restoration therapy.
5. The method of claim 4 , wherein the microbiotia restoration therapy composition includes bacteria from at least two orders and at least seven different families.
6. The method of claim 4 , wherein the microbiota restoration therapy composition has a Shannon Diversity Index of 0.4-2.5 when calculated at the family level.
7. The method of claim 5 , wherein in the range of 40-60% of the bacteria is from the order Bacteroidales, in the range of 30-40% of the bacteria is from the order Clostridiales, and in the range of 36-48% of the bacteria is from the family Bacteroidaceae.
8. The method of claim 1 , wherein the viability of the microbiota within the filtrate is confirmed by culturing the microbiota on a Bacteroides Bile Esculin Agar (BBE) plate, a Center for Disease Control (CDC) plate, or both.
9. The method of claim 1 , wherein the viability of the microbiota within the filtrate is confirmed on a BBE plate by a colony forming unit (CFU) count of about 30 CFU to about 300 CFU at a serial dilution of 10 −5 .
10. The method of claim 1 , wherein a volume of the microbiota restoration therapy composition administered is about 50 milliliters.
11. A method for treating an imbalance of the intestinal bacterial flora, the method comprising:
administering a microbiota restoration therapy composition to a patient with imbalance of the intestinal bacterial flora;
wherein the microbiota restoration therapy composition is manufactured by:
collecting a fresh human fecal sample;
adding a diluent to the fresh human fecal sample to form a diluted sample;
wherein the diluent includes 30-90 g/L polyethylene glycol in saline;
mixing the diluted sample with a mixing apparatus; and
filtering the mixture to form a filtrate, the filtrate forming the microbiota restoration therapy composition;
wherein the microbiota restoration therapy is pre-screened for bacterial diversity and includes bacteria from six or more different taxonomic families.
12. The method of claim 11 , wherein administering the microbiota restoration therapy composition to the patient with dysbiosis includes administering the microbiota restoration therapy via an enema tube.
13. The method of claim 11 , wherein administering the microbiota restoration therapy composition to the patient with dysbiosis includes administering the microbiota restoration therapy composition orally.
14. The method claim 11 , wherein the largest population of the bacteria included in the microbiota restoration therapy composition is from the family Bacteroidaceae.
15. The method claim 11 , wherein the largest population of the bacteria included in the microbiota restoration therapy composition is from the family Ruminococcaceae.
16. The method of claim 11 , wherein the largest population of the bacteria included in the microbiota restoration therapy composition is from the order Bacteroidales.
17. The method of claim 14 , wherein the second largest population of the bacteria included in the processed human fecal preparation is from the family Ruminococcaceae or Rikenellaceae.
18. The method of claim 17 , wherein the third largest population of the bacteria included in the processed human fecal preparation is from the family Ruminococcaceae, Rikenellaceae, Eubacteriaceae, Clostridiaceae, or Lachnospiraceae.
19. A method for treating an imbalance of the intestinal bacterial flora, the method comprising:
administering a microbiota restoration therapy composition to a patient with an imbalance of the intestinal bacterial flora; and
wherein the microbiota restoration therapy composition comprises a mixture of an effective amount of fecal microbiota from a fresh human fecal sample and a mixture of polyethylene glycol and saline, the polyethylene glycol added to the fresh human stool sample at a concentration of 30-90 g/L.