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Clinical Trials/NCT03751930
NCT03751930
Completed
N/A

Intestinal Microbiota, Tryptophan and Autism

University Hospital, Tours2 sites in 1 country66 target enrollmentJanuary 2, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University Hospital, Tours
Enrollment
66
Locations
2
Primary Endpoint
Urinary concentrations of tryptophan metabolites
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation. Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that is performed classically during the first three years of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to diagnose and manage.

The overall goal of this project is the identification of metabolic biomarkers based on clinical profile. The best characterization of physiopathological pathways will ultimately allow the identification of subgroups of subjects and facilitate the development of targeted therapeutics.

The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in Autism Spectrum Disorder via the gut microbiota.

Detailed Description

Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation. In France, Autism Spectrum Disorderaffects about 1 in 100 people according to international criteria and is diagnosed in early childhood. Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that is performed classically during the first three years of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to diagnose and manage. The overall goal of this project is the identification of metabolic biomarkers based on clinical profile (based on behavioral and cognitive markers). The best characterization of physiopathological pathways (from the molecular scale to the phenotypic scale) will ultimately allow the identification of subgroups of subjects and facilitate the development of targeted therapeutics. The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in Autism Spectrum Disorder via the gut microbiota.

Registry
clinicaltrials.gov
Start Date
January 2, 2019
End Date
October 28, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Urinary concentrations of tryptophan metabolites

Time Frame: At baseline

Quantification by High-Performance Liquid Chromatography and Mass Spectrometry

Faecal concentrations of tryptophan metabolites

Time Frame: At baseline

Quantification by using High-Performance Liquid Chromatography and Mass Spectrometry

Secondary Outcomes

  • Characterization of gut microbiota(At baseline)
  • Correlation of metabolic profiles of tryptophan and microbiotic profiles(At baseline)

Study Sites (2)

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