Compositions and Methods for Transplantation of Colon Microbiota
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 providing a desired donor fecal microbial community structure to a subject in need thereof, said method comprising administering to said subject an effective amount of a fecal microbe preparation from a donor having a desired fecal microbial community structure.
44 . The method of claim 43 , wherein said method further comprises administering to said an antibiotic for a period of time up to one day prior to said administering said fecal microbe preparation.
45 . The method of claim 44 , wherein said antibiotic is selected from the group comprising Metronidazole, Rifaximin, Vancomycin, Neomycin, and combinations thereof.
46 . The method of claim 43 , wherein said subject's post-administering fecal microbial community structure clusters more closely with said donor's fecal microbial community structure compared to said subject's pre-administering fecal microbial community structure based on Yue and Clayton's theta index.
47 . The method of claim 43 , wherein said subject's post-administering fecal microbial community structure remains stable for a period of time.
48 . The method of claim 47 , wherein said period of time is at least 7.5 months.
49 . The method of claim 43 , wherein the most abundant phylum of said subject's post-administering fecal microbial community structure is the phylum Firmicutes.
50 . The method of claim 43 , wherein said subject is a Clostridium difficile infection (CDI) patient having at least one prior antibiotic treatment failure.
51 . The method of claim 43 , wherein said administering is by a suitable method for depositing in the gastrointestinal tract of said subject selected from the group comprising orally administering, rectally administering, intubation through the nose, and intubation through the mouth.
52 . The method of claim 43 , wherein said donor is unrelated to said subject.
53 . The method of claim 43 , wherein said fecal microbe preparation is frozen.
54 . The method of claim 43 , wherein said fecal microbe preparation is lyophilized.
55 . The method of claim 43 , wherein said fecal microbe preparation consists essentially of particles capable of passing through a 0.5 mm sieve and an intestinal microbiota from said donor.
56 . The method of claim 43 , wherein said fecal microbe preparation comprises an extract of feces from said donor.
57 . The method of claim 43 , wherein said fecal microbe preparation comprises at least 5×10 10 cells.
58 . The method of claim 43 , wherein said subject has an inflammatory bowel disease.
59 . The method of claim 43 , wherein said subject is free of a recurrent Clostridium difficile infection for at least two months after said administering.
60 . The method of claim 59 , wherein said subject tests negative for Clostridium difficile toxin B for at least two months after said administering.
61 . The method of claim 59 , wherein said subject's diarrhea is resolved for at least two months after said administering.
62 . The method of claim 59 , wherein said subject is free of a recurrent Clostridium difficile infection for at least three months after said administering.