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 method for treating an autism spectrum disorder (ASD) in a subject in need thereof, the method comprising administering to the subject (i) a pharmaceutical composition comprising a substantially entire microbiota of a stool sample of a human donor; and (ii) a bacterial isolate comprising bacteria of the genus  Lactobacillus.    
     
     
         22 . The method of  claim 21 , wherein the pharmaceutical composition comprises the bacterial isolate. 
     
     
         23 . The method of  claim 21 , wherein the treating comprises a reduction in severity of a symptom of the ASD selected from the group consisting of: irritability, agitation, lethargy, social withdrawal, stereotypic behavior, hyperactivity, noncompliance, inappropriate speech, and a combination thereof. 
     
     
         24 . The method of  claim 23 , wherein the subject exhibits at least a 10% reduction in severity of the symptom as a result of the treating. 
     
     
         25 . The method of  claim 24 , wherein the reduction in severity of the symptom is based on an assessment system selected from the group consisting of: Childhood Autism Rating Scale (CARS), Childhood Autism Rating Scale 2-Standard Form (CARS2-ST), Childhood Autism Rating Scale 2-High Functioning (CARS2-HF), and a combination thereof. 
     
     
         26 . The method of  claim 21 , wherein the subject is a human below the age of 18. 
     
     
         27 . The method of  claim 21 , wherein the subject is a human adult. 
     
     
         28 . The method of  claim 21 , wherein at least one of the pharmaceutical composition and the bacterial isolate is administered orally. 
     
     
         29 . The method of  claim 21 , wherein the method further comprises pretreating the subject with an antibiotic. 
     
     
         30 . The method of  claim 21 , wherein the subject exhibits one or more gastrointestinal symptoms selected from the group consisting of: abdominal pain, reflux, indigestion, irritable bowel syndrome, chronic persistent diarrhoea, diarrhoea, flatulence, constipation, and alternating constipation/diarrhoea. 
     
     
         31 . The method of  claim 21 , wherein the ASD is selected from the group consisting of: autistic disorder, pervasive developmental disorder not otherwise specified (PDD-NOS), and Asperger syndrome. 
     
     
         32 . The method of  claim 21 , wherein the pharmaceutical composition and the bacterial isolate are formulated together in a geltab, pill, microcapsule, capsule, or tablet. 
     
     
         33 . A method for treating an autism spectrum disorder (ASD) in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising (i) a microbiota extracted from a stool sample of a human donor; and (ii) cultured bacteria comprising bacteria of the genus  Lactobacillus.    
     
     
         34 . The method of  claim 33 , wherein the treating comprises a reduction in severity of a symptom of the ASD selected from the group consisting of: irritability, agitation, lethargy, social withdrawal, stereotypic behavior, hyperactivity, noncompliance, inappropriate speech, and a combination thereof. 
     
     
         35 . The method of  claim 34 , wherein the reduction in the severity of the symptom is based on an assessment system selected from the group consisting of: Childhood Autism Rating Scale (CARS), Childhood Autism Rating Scale 2-Standard Form (CARS2-ST), Childhood Autism Rating Scale 2-High Functioning (CARS2-HF), and a combination thereof. 
     
     
         36 . The method of  claim 33 , wherein the subject is a human below the age of 18. 
     
     
         37 . The method of  claim 33 , wherein the subject is a human adult. 
     
     
         38 . The method of  claim 33 , wherein the pharmaceutical composition is administered orally. 
     
     
         39 . The method of  claim 33 , wherein the method further comprises pretreating the subject with an antibiotic. 
     
     
         40 . The method of  claim 33 , wherein the subject exhibits one or more gastrointestinal symptoms selected from the group consisting of: abdominal pain, reflux, indigestion, irritable bowel syndrome, chronic persistent diarrhoea, diarrhoea, flatulence, constipation, and alternating constipation/diarrhoea. 
     
     
         41 . The method of  claim 33 , wherein the ASD is selected from the group consisting of: autistic disorder, pervasive developmental disorder not otherwise specified (PDD-NOS), and Asperger syndrome. 
     
     
         42 . The method of  claim 33 , wherein the pharmaceutical composition and the bacterial isolate are formulated together in a geltab, pill, microcapsule, capsule, or tablet.