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

Abstract

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.

What is claimed is: 
     
         1 . A method for treating hepatic encephalopathy, the method comprising:
 administering a microbiota restoration therapy composition to a patient with hepatic encephalopathy;   wherein the microbiota restoration therapy composition is manufactured by:
 collecting a fecal sample from a donor; 
 wherein the donor is pre-screened for one or more of  C. difficile , a norovirus, an adenovirus, an enteric pathogen, an antigens to a  Giardia  species, bacteria from the species  Cryptosporidia , a vancomycin-resistant enterococci (VRE), a methicillin-resistant  Staphylococcus aureus , and a spore-forming parasite; 
 adding a cryoprotectant to the fecal sample to form a diluted sample; 
 mixing the diluted sample with a mixing apparatus; and 
 filtering the mixture to form a filtrate. 
   
     
     
         2 . The method of  claim 1 , wherein administering a microbiota restoration therapy composition to a patient with hepatic encephalopathy includes administering the microbiota restoration therapy composition with a colonoscope. 
     
     
         3 . The method of  claim 1 , wherein administering a microbiota restoration therapy composition to a patient with hepatic encephalopathy includes administering the microbiota restoration therapy composition by enema. 
     
     
         4 . The method of  claim 1 , wherein administering a microbiota restoration therapy composition to a patient with hepatic encephalopathy includes administering the microbiota restoration therapy composition orally. 
     
     
         5 . The method of  claim 1 , 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. 
     
     
         7 . The method of  claim 6 , 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. 
     
     
         8 . 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. 
     
     
         9 . A method for treating a liver disorder, the method comprising:
 administering a microbiota restoration therapy composition to a patient with a liver disorder, the microbiota restoration therapy composition comprising a processed fecal sample and a diluent, the diluent including 30-90 g/L polyethylene glycol in saline.   
     
     
         10 . The method of  claim 9 , wherein administering a microbiota restoration therapy composition to a patient with a liver disorder includes administering the microbiota restoration therapy composition with a colonoscope. 
     
     
         11 . The method of  claim 9 , wherein administering a microbiota restoration therapy composition to a patient with a liver disorder includes administering the microbiota restoration therapy composition by enema. 
     
     
         12 . The method of  claim 9 , wherein administering a microbiota restoration therapy composition to a patient with a liver disorder includes administering the microbiota restoration therapy composition orally. 
     
     
         13 . The method of  claim 9 , further comprising administering a secondary microbiota restoration therapy composition orally. 
     
     
         14 . The method of  claim 9 , further comprising administering a pre-treatment antibiotic to the patient. 
     
     
         15 . The method of  claim 14 , 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 9 , 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 9 , wherein the liver disorder includes hepatic encephalopathy. 
     
     
         18 . The method of  claim 9 , wherein the liver disorder is characterized by hyperammonemia. 
     
     
         19 . The method of  claim 9 , wherein the liver disorder includes cirrhosis. 
     
     
         20 . A method for treating hepatic encephalopathy, the method comprising:
 administering a microbiota restoration therapy composition to a patient with hepatic encephalopathy, the microbiota restoration therapy composition comprising a pre-screened fecal sample and a diluent, the pre-screened fecal sample being pre-screened for one or more of  C. difficile , a norovirus, an adenovirus, an enteric pathogen, an antigens to a  Giardia  species, bacteria from the species  Cryptosporidia , a vancomycin-resistant enterococci (VRE), a methicillin-resistant  Staphylococcus aureus , and a spore-forming parasite.