Methods for treating autism spectrum disorder and associated symptoms

Abstract

The present disclosure relates to compositions and methods for treating autism spectrum disorder (ASD) by restoring an ASD patient's gut microbiota. These methods can be used with ASD patient with or without ongoing gastrointestinal symptoms. Provided here is a method for ASD treatment in a subject in need thereof comprising or consisting essentially of administering a therapeutic composition comprising a fecal microbe or a fecal microbiota preparation to the subject. Also provided here is a method comprises administering an antibiotic to a human subject; subjecting the human subject to a bowel cleanse; and administering purified fecal microbiota to the human subject. Further provided are evaluation and quantitative characterization of patient symptom improvements upon treatment described here.

1 - 20 . (canceled) 
     
     
         21 . A pharmaceutical composition comprising a mixture of (a) a substantially entire microbiota of a stool sample of a human donor; and (b) a bacterial isolate comprising bacteria of the genus  Lactobacillus.    
     
     
         22 . The pharmaceutical composition of  claim 21 , wherein the bacterial isolate is derived from a human. 
     
     
         23 . The pharmaceutical composition of  claim 21 , wherein the bacterial isolate is derived from a human different from the human donor. 
     
     
         24 . The pharmaceutical composition of  claim 21 , wherein the bacterial isolate comprises cultured bacteria. 
     
     
         25 . The pharmaceutical composition of  claim 21 , wherein the bacteria of the genus  Lactobacillus  comprise  Lactobacillus leichmannii.    
     
     
         26 . The pharmaceutical composition of  claim 21 , wherein the pharmaceutical composition comprises a cryoprotectant. 
     
     
         27 . The pharmaceutical composition of  claim 26 , wherein the cryoprotectant comprises trehalose. 
     
     
         28 . The pharmaceutical composition of  claim 21 , wherein the pharmaceutical composition comprises a diluent selected from the group consisting of sugar, starch, powdered milk, microcrystalline cellulose, and a combination thereof. 
     
     
         29 . The pharmaceutical composition of  claim 28 , wherein the diluent comprises microcrystalline cellulose. 
     
     
         30 . The pharmaceutical composition of  claim 21 , wherein at least one of the microbiota and the bacterial isolate is lyophilized. 
     
     
         31 . The pharmaceutical composition of  claim 21 , wherein the pharmaceutical composition comprises an amino acid. 
     
     
         32 . The pharmaceutical composition of  claim 21 , for use in the treatment of autism spectrum disorder (ASD) in a subject in need thereof. 
     
     
         33 . A pharmaceutical composition comprising a mixture of (a) a microbiota extracted from a stool sample of a human donor; and (b) cultured bacteria comprising bacteria of the genus  Lactobacillus.    
     
     
         34 . The pharmaceutical composition of  claim 33 , wherein the bacteria of the genus  Lactobacillus  are derived from a human. 
     
     
         35 . The pharmaceutical composition of  claim 33 , wherein the bacteria of the genus  Lactobacillus  are derived from a human different from the human donor. 
     
     
         36 . The pharmaceutical composition of  claim 33 , wherein at least one of the microbiota and the cultured bacteria comprise lyophilized bacteria. 
     
     
         37 . The pharmaceutical composition of  claim 33 , wherein the pharmaceutical composition comprises a cryoprotectant. 
     
     
         38 . The pharmaceutical composition of  claim 33 , wherein the pharmaceutical composition comprises an amino acid. 
     
     
         39 . The pharmaceutical composition of  claim 33 , wherein the microbiota is a substantially complete microbiota of the stool sample. 
     
     
         40 . The pharmaceutical composition of  claim 33 , for use in the treatment of autism spectrum disorder (ASD) in a subject in need thereof. 
     
     
         41 . A pharmaceutical composition comprising a substantially entire microbiota of a stool sample of a human donor and enhanced with a bacterial isolate comprising bacteria of the genus  Lactobacillus.    
     
     
         42 . The pharmaceutical composition of  claim 41 , wherein said bacterial isolate is derived from a human different from said human donor.