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 displacing a pathogenic organism in the digestive tract, the method comprising:
manufacturing a microbiota restoration composition, wherein manufacturing the microbiota restoration composition comprises:
collecting a human fecal sample, and
adding a mixture of polyethylene glycol and saline having a concentration of 30-90 grams of polyethylene glycol per liter of saline to the human fecal sample;
administering a first dose of the microbiota restoration composition to a patient with a gastrointestinal disorder;
ascertaining a need for further treatment, wherein the need for further treatment comprises a recurrence of symptoms within 8 weeks of administering the first dose of the microbiota restoration composition to the patient; and
administering a second dose of the microbiota restoration composition to the patient when the need for further treatment occurs.
2. The method of claim 1 , further comprising administering a pre-treatment antibiotic prior to administering the first dose of the microbiota restoration composition to the patient.
3. The method of claim 1 , further comprising administering a pre-treatment antibiotic prior to administering the second dose of the microbiota restoration composition to the patient.
4. The method of claim 1 , further comprising administering a post-treatment antibiotic after administering the first dose of the microbiota restoration composition to the patient.
5. The method of claim 1 , further comprising administering a post-treatment antibiotic after administering the second dose of the microbiota restoration composition to the patient.
6. The method of claim 1 , wherein administering a first dose of the microbiota restoration composition to a patient comprises administering an enema.
7. The method of claim 1 , wherein administering a first dose of the microbiota restoration composition to a patient comprises orally administering the first dose of the microbiota restoration composition.
8. The method of claim 1 , wherein administering a second dose of the microbiota restoration composition to a patient comprises administering an enema.
9. The method of claim 1 , wherein administering a second dose of the microbiota restoration composition to a patient comprises orally administering the second dose of the microbiota restoration composition.
10. The method of claim 1 , wherein the gastrointestinal-disorder comprises a C. difficile infection.
11. The method of claim 1 , wherein the gastrointestinal disorder comprises cancer.
12. A method for displacing a pathogenic organism in the digestive tract, the method comprising:
manufacturing a microbiota restoration composition and wherein manufacturing the microbiota restoration composition comprises:
collecting a human fecal sample, and
adding a mixture of polyethylene glycol and saline having a concentration of 30-90 grams of polyethylene glycol per liter of saline to the human fecal sample;
administering a pre-treatment antibiotic to a patient with a disorder;
administering a primary dosage of the microbiota restoration composition to the patient;
ascertaining a need for further treatment, wherein the need for further treatment comprises a recurrence of symptoms within 8 weeks of administering the primary dosage of the microbiota restoration composition to the patient; and
administering a secondary dosage of the microbiota restoration composition to the patient when the need for further treatment occurs.
13. The method of claim 12 , wherein the microbiota restoration composition is derived from a single donor.
14. The method of claim 12 , wherein the pre-treatment antibiotic comprises vancomycin, fidaxomicin, rifaximimin, linezolid, daptomycin, quinupristin-dalfopristin, tigecycline, ceftaroline, ceftobiprole, televancin, teicoplanin, dalbavancin, metronidazole, ortivancin, or a combination thereof.
15. The method of claim 12 , further comprising administering a post-treatment antibiotic.
16. The method of claim 12 , wherein administering a primary dosage of the microbiota restoration composition to the patient, administering a secondary dosage of the microbiota restoration composition to the patient when the need for further treatment occurs, or both includes administering an enema.
17. The method of claim 12 , wherein administering a primary dosage of the microbiota restoration composition to the patient, administering a secondary dosage of the microbiota restoration composition to the patient when the need for further treatment occurs, or both includes oral administration.
18. The method of claim 12 , wherein the disorder comprises a C. difficile infection.
19. The method of claim 12 , wherein the disorder comprises cancer.
20. A method for displacing a pathogenic organism in the digestive tract, the method comprising:
collecting a human fecal sample;
adding a mixture of polyethylene glycol and saline having a concentration of 30-90 grams of polyethylene glycol per liter of saline to the human fecal sample to form a diluted sample;
filtering the diluted sample to form a microbiota restoration composition;
administering a pre-treatment antibiotic to a patient with a gastrointestinal disorder;
administering a primary dosage of the microbiota restoration composition to the patient;
ascertaining a need for further treatment; and
administering a secondary dosage of the microbiota restoration composition to the patient.