Intestinal Microbiota, Tryptophan and Autism (MTA)

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Samples

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Child psychiatry department, University Hospital, Tours
  • Tours, France, 37044
    • Clinical investigation center, University Hospital, Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

3-12 year old children with and without Autism Spectrum Disorders

Description

Inclusion Criteria (patient):

• 3-12 year old child
• Diagnosis of Autism Spectrum Disorders according to the DSM-5 (2013), invasive developmental disorder according to the ICD-10 (1993) or Autism Spectrum Disorders according to ICD-11 (2018)
• Affiliate or beneficiary of a social security scheme
• Consent signed by at least one of the parents

Exclusion Criteria (patient):

• Chronic inflammatory pathology
• Probiotic intake
• Taking medication (except melatonin) within 6 days before inclusion and until biological samples are collected

Inclusion Criteria (healthy volunteer):

• 3-12 year old child
• Affiliate or beneficiary of a social security scheme
• Consent signed by both parents

Exclusion Criteria (healthy volunteer):

• Chronic inflammatory pathology
• Digestive pathology
• Probiotic intake
• Taking medication within 6 days before inclusion and until biological samples are collected
• Personal and / or family history of neurological disease, epilepsy, psychiatric disorder, neurodevelopmental disorder, language disorder, overdrive, intellectual disability

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Autism Spectre Disorders; Taken biological samples on patients with Autism Spectre Disorders	Other: Samples; Urinary and faecal samples
Healthy volunteers; Taken biological samples on patients healthy volunteers	Other: Samples; Urinary and faecal samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary concentrations of tryptophan metabolites	Quantification by High-Performance Liquid Chromatography and Mass Spectrometry	At baseline
Faecal concentrations of tryptophan metabolites	Quantification by using High-Performance Liquid Chromatography and Mass Spectrometry	At baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Patrick EMOND, MD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): October 28, 2021
• Study Completion (Actual): October 28, 2021

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Gut microbiota; Autism Spectrum Disorder; Tryptophan metabolism
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: DR180136; 2018-A01086-49 (Other Identifier: IdRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No