Method for treatment of disorders of the gastrointestinal system

Abstract

There are provided novel synthetic stool preparations comprising bacteria isolated from a fecal sample from a healthy donor. The synthetic stool preparations are used for treating disorders of the gastrointestinal tract, including dysbiosis, Clostridium difficile infection and recurrent Clostridium difficile infection, prevention of recurrence of Clostridium difficile infection, treatment of Crohn's disease, ulcerative colitis, irritable bowel syndrome, inflammatory bowel disease, and diverticular disease, and treatment of food poisoning such as salmonella . Methods of preparation and methods of use of the synthetic stool preparations are also provided.

We claim: 
     
         1 . A method for treating a disorder associated with dysbiosis of the gastrointestinal tract, comprising administering the synthetic stool preparation comprising a plurality of bacterial strains, wherein the plurality comprises at least four of a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical to SEQ ID NO: 4 or comprising SEQ ID NO: 4,
 a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 2 or comprising SEQ ID NO: 2,   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 13 or comprising SEQ ID NO: 13,   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 12 or comprising SEQ ID NO: 12,   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 11 or comprising SEQ ID NO: 11,   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 27 or comprising SEQ ID NO: 27,   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 1 or comprising SEQ ID NO: 1,   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 20 or comprising SEQ ID NO: 20,   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 29 or comprising SEQ ID NO: 29,   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 30 or comprising SEQ ID NO: 30,   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 24 or comprising SEQ ID NO: 24,   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 18 or comprising SEQ ID NO: 18,   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 14 or comprising SEQ ID NO: 14, or   a bacterial strain having a 16S rRNA nucleic acid sequence at least 97% identical SEQ ID NO: 16 or comprising SEQ ID NO: 16,   to a subject in need thereof, wherein the subject has inflammatory bowel disease.   
     
     
         2 . The method of  claim 1 , wherein administration is via rectal enema by the colonoscopic route. 
     
     
         3 . The method of  claim 2 , comprising the steps of:
 inserting a colonoscope into the cecum of the subject;   optionally suctioning a sample of fecal material from the area;   depositing a first portion of the synthetic stool preparation adjacent to the cecum, using a syringe containing the synthetic stool preparation attached to the colonoscope; and   depositing a second portion of the synthetic stool preparation throughout the transverse colon using the syringe as the colonoscope is withdrawn.   
     
     
         4 . The method of  claim 1 , wherein the subject does not receive antibiotic therapy for at least 3 days before administration of the synthetic stool preparation. 
     
     
         5 . The method of  claim 1 , wherein the subject is treated with a colon cleansing agent before administration of the synthetic stool preparation. 
     
     
         6 . The method of  claim 1 , wherein the subject has  Clostridium difficile  infection or recurrent  Clostridium difficile  infection, or wherein recurrence of  Clostridium difficile  infection is prevented. 
     
     
         7 . The method of  claim 1 , wherein the subject has Crohn's disease, ulcerative colitis, irritable bowel syndrome, inflammatory bowel disease, diverticular disease, or food poisoning. 
     
     
         8 . The method of  claim 1 , wherein inflammation is reduced in the subject after administration of the synthetic stool preparation. 
     
     
         9 . The method of  claim 1 , wherein the synthetic stool preparation is administered orally. 
     
     
         10 . The method of  claim 10 , wherein the synthetic stool preparation is freeze-dried and/or is in capsule or tablet form.