Intestinal Microbiota, Tryptophan and Autism

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Samples

• Registration Number: NCT03751930
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Study Start: 2019-01-02
• Primary Completion: 2021-10-28
• Study Completion: 2021-10-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Samples	Taken biological samples on patients healthy volunteers
Patients with Autism Spectre Disorders	Samples	Taken biological samples on patients with Autism Spectre Disorders

Primary Outcome Measures

Name	Time	Method
Faecal concentrations of tryptophan metabolites	At baseline	Quantification by using High-Performance Liquid Chromatography and Mass Spectrometry
Urinary concentrations of tryptophan metabolites	At baseline	Quantification by High-Performance Liquid Chromatography and Mass Spectrometry

Secondary Outcome Measures

Name	Time	Method
Characterization of gut microbiota	At baseline	Characterization by 16S ribosomal RNA sequencing
Correlation of metabolic profiles of tryptophan and microbiotic profiles	At baseline	Study of correlations from the outcomes measures 1, 2 and 3

Trial Locations

Locations (2)

Clinical investigation center, University Hospital, Tours; 🇫🇷 Tours, France

Child psychiatry department, University Hospital, Tours; 🇫🇷 Tours, France