Compositions and methods

Abstract

Provided are defined bacterial compositions for the maintenance or restoration of a healthy microbiota in the gastrointestinal tract of a mammalian subject, and methods for populating the gastrointestinal tract of a subject. Provided also are bacterial formulations for oral or gastric administration to a mammalian subject in an effective amount for prevention or treatment of a gastrointestinal disease, disorder or condition.

1 - 43 . (canceled) 
     
     
         44 . A method of treating a mammalian subject suffering from or at risk of developing a gastrointestinal disease, disorder or condition, comprising administering to the mammalian subject in need thereof a composition comprising
 a bacterial population consisting of from seven to nine isolated bacterial strains, wherein two of the bacterial strains are  Clostridium innocuum  and  Blautia producta;  and   a capsule substantially encapsulating the bacterial population.   
     
     
         45 . The method of  claim 44 , wherein the gastrointestinal disease, disorder or condition is relapsing diarrhea caused by  Clostridium difficile,  ulcerative colitis, colitis, Crohn's disease, or irritable bowel disease. 
     
     
         46 . The method of  claim 44 , wherein the gastrointestinal disease, disorder or condition is recurrent  Clostridium difficile  infection. 
     
     
         47 . The method of  claim 44 , wherein the gastrointestinal disease, disorder or condition is  Clostridium difficile  infection. 
     
     
         48 . The method of  claim 44 , wherein the composition is administered once a day for several days or more than once a day on the day of administration. 
     
     
         49 . The method of  claim 44 , wherein the composition is administered once prior to improvement of the disease, disorder or condition. 
     
     
         50 . The method of  claim 44 , wherein the composition is administered at intervals greater than two days. 
     
     
         51 . The method of  claim 44 , wherein the mammalian subject has not received at least two doses of a vancomycin, a metronidazole, or an antibiotic compound within one week prior to administration of the composition. 
     
     
         52 . The method of  claim 44 , wherein the mammalian subject is not suffering from relapsing diarrhea caused by  C. difficile.    
     
     
         53 . The method of  claim 44 , wherein the mammalian subject has received an antibiotic prior to administration of the composition. 
     
     
         54 . The method of  claim 53 , wherein the antibiotic is an aminoglycoside antibiotic, amoxicillin, ampicillin, Augmentin, a cephalosporin, clavulanate potassium, clindamycin, colistin gentamycin, kanamycin, metronidazole, vancomycin, or a combination thereof. 
     
     
         55 . The method of  claim 44 , wherein the mammalian subject has not previously received an antibiotic compound in the one month prior to administration of the composition. 
     
     
         56 . The method of  claim 44 , wherein the composition is formulated for oral or gastric administration. 
     
     
         57 . The method of  claim 44 , wherein the bacterial strains are present at a concentration of at least 1×10 4  viable bacteria. 
     
     
         58 . The method of  claim 44 , wherein at least one of the bacterial strains is provided in a concentration of greater than 1×10 9  viable bacteria. 
     
     
         59 . The method of  claim 44 , wherein the bacterial population consists of seven bacterial strains. 
     
     
         60 . The method of  claim 44 , wherein the bacterial population consists of eight bacterial strains. 
     
     
         61 . The method of  claim 44 , wherein the bacterial population consists of nine bacterial strains. 
     
     
         62 . The method of  claim 44 , wherein the composition further comprises an excipient. 
     
     
         63 . The method of  claim 44 , wherein the bacterial strains are lyophilized. 
     
     
         64 . The method of  claim 44 , wherein the bacterial strains are in vegetative form. 
     
     
         65 . The method of  claim 44 , wherein the bacterial strains are in spore form. 
     
     
         66 . A method of treating recurrent  Clostridium difficile  infection in a subject in need thereof, comprising administering to the subject a composition comprising
 a bacterial population consisting of from seven to nine isolated bacterial strains, wherein two of the bacterial strains are  Clostridium innocuum  and  Blautia producta;  and   a capsule substantially encapsulating the bacterial population.