US2021379123A1PendingUtilityA1

Probiotic therapies for developmental disorders and other neurological disorders

Assignee: BAYLOR COLLEGE MEDICINEPriority: Apr 15, 2016Filed: Aug 24, 2021Published: Dec 9, 2021
Est. expiryApr 15, 2036(~9.7 yrs left)· nominal 20-yr term from priority
A23C 9/1234A23V 2002/00A61K 9/02A61K 35/747A61K 2035/115A61P 25/00A61K 9/0053A61K 9/20A61P 25/20A61K 35/742A61P 25/28A23V 2400/173
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Claims

Abstract

Embodiments of the disclosure concern methods and compositions related to manipulation of the microbiome in an individual having at least one social behavior deficit. In particular embodiments, an individual has at least one social behavior deficit and was born from a mother who during pregnancy was obese, overweight, or on a high-fat diet during pregnancy or carries mutations associated with neurodevelopmental disorders. In specific embodiments, the individual having at least one social behavior deficit is provided an effective amount of Lactobacillus reuteri for the improvement of at least one symptom of a social behavior deficit.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of treating or preventing one or more social behavioral deficiencies in an individual with neurodevelopmental, neurodegenerative, and/or psychiatric disorders, comprising the steps of providing to the individual and/or the mother during gestation of the individual a therapeutically effective amount of a formulation comprising  Lactobacillus reuteri  and/or a bioactive extract or fraction thereof. 
     
     
         2 . The method of  claim 1 , wherein when providing the formulation to the individual, the mother of the individual was obese, overweight, or on a high-fat diet during the pregnancy with the individual or the mother had an altered gut microbiome. 
     
     
         3 . The method of  claim 1 , wherein when providing the formulation to the mother during gestation of the individual. 
     
     
         4 . The method of  claim 1 ,  2  or  3 , wherein the social behavioral deficiency comprises impaired sociability, preference for social novelty, difficulty in social use of verbal and nonverbal communication, or a combination thereof. 
     
     
         5 . The method of any one of  claims 1 - 4 , wherein the individual has a neurodevelopment disorder. 
     
     
         6 . The method of any one of  claims 1 - 5 , wherein the individual has autism spectrum disorder or other neurological disorders associated with social dysfunction. 
     
     
         7 . The method of any one of  claims 1 - 6 , further comprising the step of identifying that the mother is or was obese, overweight, or on a high-fat diet during pregnancy with the individual and wherein the formulation is provided to the individual or mother intentionally to treat or prevent the social behavior deficiency in the individual. 
     
     
         8 . The method of any one of  claims 1 - 7 , wherein the formulation comprises an additional bacteria species or nutrient(s). 
     
     
         9 . The method of any one of  claims 1 - 8 , wherein the formulation is delivered via a pill or suppository. 
     
     
         10 . The method of any one of  claims 1 - 8 , wherein the formulation is a food, beverage, yogurt, dry powder, or dry powder mixed in water or beverage. 
     
     
         11 . The method of any one of  claims 1 - 10 , wherein the individual is given an effective amount of one or more other bacteria species than  L. reuteri , one or more prebiotics or other nutrients, and/or behavioral therapy. 
     
     
         12 . The method of  claim 11 , wherein the nutrient is one or more of vitamins, lipids, or proteins. 
     
     
         13 . The method of any one of  claims 1 - 12 , wherein the individual has or is at risk of having one or more of William Syndrome, Prader-Willi syndrome, Fragile X syndrome, one or more addictive behaviors, bipolar disorder, Schizophrenia, Depression, Postpartum depression, anxiety, Parkinson's disease, Social cognitive impairment, and/or Alzheimer's Disease. 
     
     
         14 . The method of  claim 13 , wherein the addictive behavior concerns one or more of food, alcohol, drugs, gambling, inhalants and tobacco. 
     
     
         15 . A method of  claims 1 - 14  in which  L. reuteri  or a biologically active extract, lysate, semipurified or purified active molecule(s) from  L. reuteri  are taken as prophylactic therapy for the promotion of general wellbeing, brain health, mood and/or social behaviors and social memory.

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