Microbiota restoration therapy (MRT), composition 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 fecal microbiota suspension, comprising:
fecal microbiota and
a polyethylene glycol solution,
wherein the polyethylene glycol solution is prepared by a process comprising adding 30 90 g polyethylene glycol to 1 L saline,
wherein the fecal microbiota suspension comprises >1×10 5 colony forming units (CFU) Bacteroides per mL.
2. The fecal microbiota suspension of claim 1 , wherein the suspension is prepared by a process comprising adding the polyethylene glycol solution to a sample of human fecal material, and filtering the fecal microbiota suspension.
3. The fecal microbiota suspension of claim 1 , wherein the suspension is disposed in a sample bag, wherein the fecal microbiota suspension in the sample bag comprises >1×10 5 colony forming units (CFU) Bacteroides per mL.
4. A method of preparing a fecal microbiota suspension, comprising:
adding a polyethylene glycol solution to a sample of human fecal material,
wherein the polyethylene glycol solution is prepared by a process comprising adding 30 90 g polyethylene glycol to 1 L saline,
wherein the fecal microbiota suspension comprises >1×10 5 colony forming units (CFU) Bacteroides per mL.
5. The method of claim 4 , further comprising filtering the fecal microbiota suspension.
6. The method of claim 4 , further comprising filtering the fecal microbiota suspension and transferring the filtrate to a sample bag, wherein the fecal microbiota suspension in the sample bag comprises >1×10 5 colony forming units (CFU) Bacteroides per mL.
7. A fecal microbiota composition prepared by the process of claim 4 .
8. A fecal microbiota composition disposed in a sample bag prepared by the process of claim 6 .
9. A method of treatment, comprising administering the fecal microbiota suspension of claim 1 to a patient in need thereof.
10. A method of treatment, comprising administering the fecal microbiota suspension of claim 3 to a patient in need thereof.
11. A method of treatment, comprising administering the fecal microbiota suspension of claim 7 to a patient in need thereof.
12. A method of treatment, comprising administering the fecal microbiota suspension of claim 8 to a patient in need thereof.