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

摘要

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.

主权项

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, andfiltering; 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.