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 hepatic encephalopathy, the method comprising:
administering a primary microbiota restoration therapy composition to a patient with hepatic encephalopathy;
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 fecal sample and a cryoprotectant, the cryoprotectant comprising polyethylene glycol at a concentration of 30-90 g/L in saline.
2. The method of claim 1 , wherein administering a primary microbiota restoration therapy composition to a patient with hepatic encephalopathy includes administering a microbiota restoration therapy composition with a colonoscope.
3. The method of claim 2 , further comprising administering a secondary microbiota restoration therapy composition with an enema.
4. The method of claim 1 , wherein administering a primary microbiota restoration therapy composition to a patient with hepatic encephalopathy includes administering a microbiota restoration therapy composition orally.
5. The method of claim 4 , further comprising administering a secondary microbiota restoration therapy composition orally.
6. The method of claim 1 , further comprising administering a pre-treatment antibiotic to the patient, wherein the pre-treatment antibiotic includes vancomycin, fidaxomicin, rifaximin, linezolid, daptomycin, quinupristin-dalfopristin, tigecycline, ceftaroline, ceftobiprole, televancin, teicoplanin, dalbavancin, metronidazole, ortivancin, or a combination thereof.
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 , wherein administering a microbiota restoration therapy composition to a patient with hepatic encephalopathy includes manufacturing the microbiota restoration therapy composition and wherein manufacturing the microbiota restoration therapy composition comprises:
collecting a human fecal sample;
adding 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.
9. 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.
10. A method of treating hepatic encephalopathy, the method comprising:
administering a primary dose of a microbiota restoration therapy composition to a patient with hepatic encephalopathy, 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 cryoprotectant mixture to the human fecal sample at a concentration of 2-4 milliliters of the cryoprotectant mixture per gram of the human fecal sample to form a diluted sample, the cryoprotectant mixture comprising 30-90 g/L of polyethylene glycol in 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 hepatic encephalopathy.
11. The method of claim 10 , wherein administering a primary microbiota restoration therapy composition to a patient with hepatic encephalopathy includes administering a microbiota restoration therapy composition with a colonoscope.
12. The method of claim 10 , wherein administering a secondary dose of the pre-screened microbiota restoration therapy composition to the patient with hepatic encephalopathy includes administering a microbiota restoration therapy composition with an enema.
13. The method of claim 10 , wherein administering a primary microbiota restoration therapy composition to a patient with hepatic encephalopathy includes administering a microbiota restoration therapy composition orally.
14. The method of claim 10 , wherein administering a secondary dose of the pre-screened microbiota restoration therapy composition to the patient with hepatic encephalopathy includes administering a microbiota restoration therapy composition orally.
15. The method of claim 10 , further comprising administering a pre-treatment antibiotic to the patient, wherein the pre-treatment antibiotic includes vancomycin, fidaxomicin, rifaximin, linezolid, daptomycin, quinupristin-dalfopristin, tigecycline, ceftaroline, ceftobiprole, televancin, teicoplanin, dalbavancin, metronidazole, ortivancin, or a combination thereof.
16. 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.
17. A method for treating a urinary tract infection, the method
comprising:
administering a primary microbiota restoration therapy composition to a patient with a urinary tract infection;
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 fecal sample and a cryoprotectant, the cryoprotectant comprising polyethylene glycol at a concentration of 30-90 g/L in saline.
18. The method of claim 17 , wherein administering a microbiota restoration therapy composition to a patient with a urinary tract infection includes administering a microbiota restoration therapy composition with an enema tube.
19. The method of claim 17 , wherein administering a microbiota restoration therapy composition to a patient with a urinary tract infection includes administering a microbiota restoration therapy composition orally.
20. The method of claim 17 , wherein the urinary tract infection comprises a drug resistant or multi-drug resistant urinary tract infection.