Compositions and Methods for Transplantation of Colon Microbiota

Abstract

The present invention provides compositions that include an extract of human feces, and methods for using such compositions, including methods for replacing or supplementing or modifying a subject's colon microbiota, and methods for treating a disease, pathological condition, and/or iatrogenic condition of the colon.

1 - 42 . (canceled) 
     
     
         43 . A method for treating a  Clostridium difficile  infection (CDI) in a subject in need thereof, said method comprising administering to said subject an effective amount of fecal microbe material that is frozen for at least once, wherein said fecal microbe material is capable of achieving a CDI clearance rate substantially similar to a CDI clearance rate achievable by fresh fecal material not previously frozen. 
     
     
         44 . The method of  claim 43 , wherein said fecal microbe material is subject to at least one freeze-thaw cycle. 
     
     
         45 . The method of  claim 43 , wherein CDI clearance is defined as CDI symptom resolution and negative PCR testing for  C. difficile  toxin B after two months post said administering. 
     
     
         46 . The method of  claim 43 , wherein said frozen is at a temperature of −20° C. or lower. 
     
     
         47 . The method of  claim 43 , wherein the most abundant phylum of said subject's post-administering fecal microbial community structure is the phylum Firmicutes. 
     
     
         48 . The method of  claim 43 , wherein said subject has had at least one prior antibiotic treatment failure for said CDI. 
     
     
         49 . The method of  claim 43 , wherein said suitable method is orally administering to said subject. 
     
     
         50 . The method of  claim 43 , wherein CDI clearance is identified by resolution of diarrhea. 
     
     
         51 . The method of  claim 43 , wherein said CDI clearance rate is determined 2 months post said administering to said subject an effective amount of said fecal microbe material. 
     
     
         52 . The method of  claim 43 , wherein said fecal microbe material consists essentially of particles capable of passing through a 0.5 mm sieve and an intestinal microbiota from a donor. 
     
     
         53 . The method of  claim 43 , wherein said fecal microbe material comprises an extract of feces from said donor. 
     
     
         54 . The method of  claim 43 , wherein said fecal microbe material comprises at least 5×10 10  cells. 
     
     
         55 . The method of  claim 43 , wherein said subject has an inflammatory bowel disease prior to said administering. 
     
     
         56 . The method of  claim 43 , wherein said subject is free of a recurrent  Clostridium difficile  infection for at least two months after said administering. 
     
     
         57 . The method of  claim 56 , wherein said subject tests negative for  Clostridium difficile  toxin B for at least two months after said administering. 
     
     
         58 . The method of  claim 56 , wherein said subject's diarrhea is resolved for at least two months after said administering. 
     
     
         59 . The method of  claim 56 , wherein said subject is free of a recurrent  Clostridium difficile  infection for at least three months after said administering. 
     
     
         60 . The method of  claim 43 , further comprising pretreating said patient with one or more antibiotics prior to said administering. 
     
     
         61 . The method of  claim 60 , wherein said one or more antibiotics are selected from the group consisting of Metroidazole, Rifaximin, Vancomycin, and Neomycin. 
     
     
         62 . A method for treating a  Clostridium difficile  infection (CDI) in a subject in need thereof, said method comprising administering to said subject an effective amount of a previously frozen fecal microbe material, wherein said fecal microbe material is capable of achieving a CDI clearance rate substantially similar to a CDI clearance rate achievable by fresh fecal material not previously frozen, wherein CDI clearance is defined as CDI symptom resolution and negative PCR testing for  C. difficile  toxin B after two months post said administering.