Microbiota restoration therapy (MRT), compositions and methods of manufacture

1. A method for treating ulcerative colitis, the method comprising:

administering a microbiota restoration therapy composition to a patient with ulcerative colitis;

wherein the microbiota restoration therapy composition is pre-screened for bacterial diversity;

wherein the pre-screened microbiota restoration therapy composition includes bacteria from at least seven different families and has a Shannon Diversity Index of 0.4-2.5 when calculated at the family level; 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.

2. The method of claim 1 , further comprising administering a pre-treatment antibiotic to the patient, wherein the pre-treatment antibiotic includes vancomycin, fidaxomicin, rifaximimin, linezolid, daptomycin, quinupristin-dalfopristin, tigecycline, ceftaroline, ceftobiprole, televancin, teicoplanin, dalbavancin, metronidazole, ortivancin, or a combination thereof.

3. The method of claim 2 , wherein the pre-treatment antibiotic is administered at a dose of 0.01 mg per day to 5000 mg per day.

4. The method of claim 2 , wherein the pre-treatment antibiotic is administered orally, by enema, or by suppository.

5. The method of claim 2 , wherein administering a pre-treatment antibiotic to the patient includes administering a single dose of the pre-treatment antibiotic to the patient.

6. The method of claim 2 , wherein administering a pre-treatment antibiotic to the patient includes administering two or more doses of the pre-treatment antibiotic to the patient.

7. The method of claim 1 , further comprising administering a post-treatment antibiotic to the patient after administering the microbiota restoration therapy composition to the patient.

8. The method of claim 1 , further comprising administering a second dose of the microbiota restoration therapy composition to the patient.

9. The method of claim 1 , wherein administering a microbiota restoration therapy composition to a patient with ulcerative colitis includes manufacturing the microbiota restoration therapy composition and wherein manufacturing the microbiota restoration therapy composition comprises:

collecting the fresh human fecal sample;

adding the polyethylene glycol to the human fecal sample to form a diluted sample;

mixing the diluted sample with a mixing apparatus;

filtering the diluted sample;

wherein filtering forms a filtrate;

transferring the filtrate to a sample bag; and

sealing the sample bag.

10. The method of claim 1 , wherein administering a microbiota restoration therapy composition to a patient with ulcerative colitis includes administering a microbiota restoration therapy composition with an enema tube.

11. The method of claim 1 , wherein administering a microbiota restoration therapy composition to a patient with ulcerative colitis includes administering a microbiota restoration therapy composition orally.

12. The method of claim 1 , wherein the microbiota restoration therapy composition includes bacteria and 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.

13. A method of treating ulcerative colitis, the method comprising:

administering a primary dose of a microbiota restoration therapy composition to a patient with ulcerative colitis, wherein the microbiota restoration therapy composition has been manufactured using the following method:

collecting a fresh human fecal sample;

placing the fresh human fecal sample into a filter bag;

adding a mixture of polyethylene glycol and saline to the human fecal sample to form a diluted sample at a concentration of 2-4 milliliters of the mixture of polyethylene glycol and saline per gram of the human fecal sample, the mixture of polyethylene glycol and saline having a concentration of 30-90 grams of polyethylene glycol per liter of saline;

mixing the diluted sample with a paddle mixer at 230 rpm for two minutes;

filtering the diluted sample;

wherein filtering forms a filtrate;

transferring the filtrate to a sample bag; and

sealing the sample bag;

wherein the microbiota restoration therapy composition is pre-screened for bacterial diversity;

wherein the pre-screened microbiota restoration therapy composition includes bacteria from at least seven different families; and

administering a secondary dose of the pre-screened microbiota restoration therapy composition to the patient with ulcerative colitis.

14. The method of claim 13 , further comprising administering a pre-treatment antibiotic to the patient, wherein the pre-treatment antibiotic includes vancomycin, fidaxomicin, rifaximimin, linezolid, daptomycin, quinupristin-dalfopristin, tigecycline, ceftaroline, ceftobiprole, televancin, teicoplanin, dalbavancin, metronidazole, ortivancin, or a combination thereof.

15. The method of claim 13 , wherein the pre-treatment antibiotic is administered at a dose of 0.01 mg per day to 5000 mg per day.

16. The method of claim 13 , wherein the pre-treatment antibiotic is administered orally, by enema, or by suppository.

17. The method of claim 13 , further comprising administering a post-treatment antibiotic to the patient after administering the microbiota restoration therapy composition to the patient.

18. The method of claim 13 , wherein administering a microbiota restoration therapy composition to a patient with ulcerative colitis includes administering a microbiota restoration therapy composition with an enema tube.

19. The method of claim 13 , wherein administering a microbiota restoration therapy composition to a patient with ulcerative colitis includes administering a microbiota restoration therapy composition orally.

20. A method of treating ulcerative colitis, the method comprising:

administering one or more doses of a microbiota restoration therapy composition to a patient with a ulcerative colitis, wherein the microbiota restoration therapy composition has been manufactured using the following method:

collecting a human fecal sample;

placing the human fecal sample into a filter bag;

adding a diluent to the human fecal sample to form a diluted sample at a concentration of 2-4 milliliters of the diluent per gram of the human fecal sample, wherein the diluent is a mixture of saline and polyethylene glycol and the concentration of polyethylene glycol in the diluent is 30-90 grams/liter;

mixing the diluted sample with a paddle mixer at 230 rpm for two minutes;

filtering the diluted sample;

wherein filtering forms a filtrate;

transferring the filtrate to a sample bag; and

sealing the sample bag;

wherein the microbiota restoration therapy composition is pre-screened for bacterial diversity and the pre-screened microbiota restoration therapy composition includes bacteria from at least two orders and at least seven different families and has a Shannon Diversity Index of 0.4-2.5 when calculated at the family level, 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.