Microbiota restoration therapy (mrt) compositions and methods of manufacture

Abstract

Microbiota restoration therapy (MRT) compositions (e.g., oral MRT compositions) and methods for manufacturing MRT compositions are disclosed. An example method for manufacturing an MRT composition may include collecting a stool sample, purifying the stool sample to form a purified sample, stabilizing the purified sample to form a stabilized sample, converting the stabilized sample to a solid, adding one or more additives and/or excipients to the solid to form a treatment composition, and encapsulating the treatment composition.

1 - 20 . (canceled) 
     
     
         21 . A microbiota restoration therapy method, comprising orally administering to a subject in need thereof a microbiota restoration therapy composition comprising a lyophilized material comprising fecal microbiota and a lyophilization excipient comprising polyethylene glycol and one or more selected from trehalose, sucrose, and glycerin. 
     
     
         22 . The method of  claim 21 , wherein the lyophilization excipient comprises polyethylene glycol and two or more selected from trehalose, sucrose, and glycerin. 
     
     
         23 . The method of  claim 21 , wherein the lyophilization excipient comprises polyethylene glycol and trehalose, sucrose, and glycerin. 
     
     
         24 . The method of  claim 21 , wherein the lyophilization excipient comprises polyethylene glycol 3550, trehalose, sucrose, and glycerin. 
     
     
         25 . The method of  claim 21 , wherein the microbiota restoration therapy composition is prepared by a process comprising:
 processing a human donor fecal sample to obtain a fecal microbiota composition; and   lyophilizing the fecal microbiota composition with a lyophilization excipient to obtain a lyophilized material, wherein the lyophilization excipient comprises polyethylene glycol and one or more selected from trehalose, sucrose, and glycerin.   
     
     
         26 . The method of  claim 21 , wherein the microbiota restoration therapy composition is administered in a capsule containing the microbiota restoration therapy composition. 
     
     
         27 . An oral microbiota restoration therapy composition prepared by a process comprising
 processing a human donor fecal sample to obtain a fecal microbiota composition;   lyophilizing the fecal microbiota composition with a lyophilization excipient to obtain a lyophilized material, wherein the lyophilization excipient comprises polyethylene glycol and one or more selected from trehalose, sucrose, and glycerin.   
     
     
         28 . The oral microbiota restoration therapy composition of  claim 27 , wherein the lyophilization excipient comprises polyethylene glycol and two or more selected from trehalose, sucrose, and glycerin. 
     
     
         29 . The oral microbiota restoration therapy composition of  claim 27 , wherein the lyophilization excipient comprises polyethylene glycol and trehalose, sucrose, and glycerin. 
     
     
         30 . The oral microbiota restoration therapy composition of  claim 27 , wherein the lyophilization excipient comprises polyethylene glycol 3550, trehalose, sucrose, and glycerin. 
     
     
         31 . The oral microbiota restoration therapy composition of  claim 27 , wherein the lyophilized material has a glass transition temperature greater than 30° C. 
     
     
         32 . The oral microbiota restoration therapy composition of  claim 27 , wherein the lyophilized material has a glass transition temperature in the range of 30-75° C. 
     
     
         33 . An oral capsule comprising the oral microbiota restoration therapy composition of  claim 27  disposed in a capsule. 
     
     
         34 . A method of preparing an oral microbiota restoration therapy composition, comprising:
 processing a human donor fecal sample to obtain a fecal microbiota composition;   lyophilizing the fecal microbiota composition with a lyophilization excipient, wherein the lyophilization excipient comprises polyethylene glycol and one or more selected from trehalose, sucrose, and glycerin, to obtain a lyophilized material.   
     
     
         35 . The method of  claim 34 , wherein the lyophilization excipient comprises polyethylene glycol and two or more selected from trehalose, sucrose, and glycerin. 
     
     
         36 . The method of  claim 34 , wherein the lyophilization excipient comprises polyethylene glycol and trehalose, sucrose, and glycerin. 
     
     
         37 . The method of  claim 34 , wherein the lyophilization excipient comprises polyethylene glycol 3550, trehalose, sucrose, and glycerin. 
     
     
         38 . The method of  claim 34 , wherein the lyophilized material has a glass transition temperature greater than 30° C. 
     
     
         39 . The method of  claim 34 , wherein the lyophilized material has a glass transition temperature in the range of 30-75° C. 
     
     
         40 . The method of  claim 34 , further comprising disposing the lyophilized material into a capsule.