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 of treating a gastrointestinal disorder, the method comprising:
administering a first pre-treatment antibiotic to a patient with a gastrointestinal disorder;
administering a second pre-treatment antibiotic to the patient with a gastrointestinal disorder;
wherein the first pre-treatment antibiotic and the second pre-treatment antibiotic are different;
administering a first dose of a microbiota restoration therapy composition to the patient;
wherein the first dose of the microbiota restoration therapy composition is manufactured by:
collecting a fresh stool sample from a human donor,
adding saline and polyethylene glycol to the fresh stool sample, the polyethylene glycol being added at a concentration of 30-90 g/L, and
filtering;
wherein the first dose of 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;
wherein the microbiota restoration therapy composition comprises a mixture of an effective amount of fecal microbiota and an effective amount of polyethylene glycol; and
administering a second dose of a microbiota restoration therapy composition to the patient.
2. The method of claim 1 , wherein the first or second 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 1 , wherein the first or second pre-treatment antibiotic is administered at a dose of 0.01 mg per day to 5000 mg per day.
4. The method of claim 1 , wherein the first or second pre-treatment antibiotic is administered orally, by enema, or by suppository.
5. The method of claim 1 , wherein administering a first or second pre-treatment antibiotic to a patient with a gastrointestinal disorder includes administering a single dose of the first or second pre-treatment antibiotic to the patient.
6. The method of claim 1 , wherein administering a first or second pre-treatment antibiotic to a patient with a gastrointestinal disorder includes administering two or more doses of the first or second 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 7 , wherein the post-treatment antibiotic is the same as one of the first or second pre-treatment antibiotic.
9. The method of claim 7 , wherein the post-treatment antibiotic is different from one of the first or second pre-treatment antibiotic.
10. The method of claim 1 , further comprising administering a second dose of the microbiota restoration therapy composition to the patient.
11. The method of claim 1 , wherein administering a first pre-treatment antibiotic to a patient with a gastrointestinal disorder includes administering two or more doses of the first pre-treatment antibiotic to the patient and wherein administering a microbiota restoration therapy composition to the patient includes administering two or more doses of the microbiota restoration therapy composition to the patient.
12. The method of claim 1 , wherein manufacturing the microbiota restoration therapy composition comprises:
wherein filtering forms a filtrate;
transferring the filtrate to a sample bag;
sealing the sample bag;
pre-cooling the sample bag; and
freezing the sample bag.
13. The method of claim 12 , wherein administering a microbiota restoration therapy composition to the patient includes thawing the sample bag and administering the microbiota restoration therapy composition with an enema tube.
14. The method of claim 1 , wherein the gastrointestinal disorder is a C. difficile infection.
15. A method of treating a gastrointestinal disorder, the method comprising:
pre-treating a patient with a gastrointestinal disorder with a primary dose of a first antibiotic, the first antibiotic including vancomycin, fidaxomicin, rifaximimin, linezolid, daptomycin, quinupristin-dalfopristin, tigecycline, ceftaroline, ceftobiprole, televancin, teicoplanin, dalbavancin, metronidazole, ortivancin, or a combination thereof;
pre-treating the patient with a secondary dose of a second antibiotic, the second antibiotic including vancomycin, fidaxomicin, rifaximimin, linezolid, daptomycin, quinupristin-dalfopristin, tigecycline, ceftaroline, ceftobiprole, televancin, teicoplanin, dalbavancin, metronidazole, ortivancin, or a combination thereof;
administering a dose of a microbiota restoration therapy composition to the patient;
wherein the microbiota restoration therapy composition is manufactured by:
collecting a fresh stool sample from a human donor,
adding saline and polyethylene glycol to the fresh stool sample, the polyethylene glycol being added at a concentration of 30-90 g/L, and
filtering;
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 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 and an effective amount of polyethylene glycol.
16. The method of claim 15 , further comprising administering a post-treatment antibiotic to the patient after administering the microbiota restoration therapy composition to the patient.
17. The method of claim 15 , further comprising administering a second dose of the microbiota restoration therapy composition to the patient.
18. The method of claim 15 , wherein administering a microbiota restoration therapy composition to the patient includes administering the microbiota restoration therapy composition with an enema tube.
19. The method of claim 15 , wherein the gastrointestinal disorder is a C. difficile infection.
20. A method of treating a gastrointestinal disorder, the method comprising:
administering a primary dose of a microbiota restoration therapy composition to the patient;
administering a secondary dose of the microbiota restoration therapy composition to the patient;
wherein the microbiota restoration therapy composition is manufactured by:
collecting a fresh stool sample from a human donor,
adding saline and polyethylene glycol to the fresh stool sample, the polyethylene glycol being added at a concentration of 30-90 g/L, and
filtering;
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 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 and an effective amount of polyethylene glycol.