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Completed

NCT Number: NCT03751930

Intestinal Microbiota, Tryptophan and Autism

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.

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Child psychiatry department, University Hospital, Tours, Tours, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samples

Other

Urinary and faecal samples

Primary outcomes

  1. Urinary concentrations of tryptophan metabolites

    Time frame: At baseline

    Quantification by High-Performance Liquid Chromatography and Mass Spectrometry

  2. Faecal concentrations of tryptophan metabolites

    Time frame: At baseline

    Quantification by using High-Performance Liquid Chromatography and Mass Spectrometry

Secondary outcomes

  1. Characterization of gut microbiota

    Time frame: At baseline

    Characterization by 16S ribosomal RNA sequencing

  2. Correlation of metabolic profiles of tryptophan and microbiotic profiles

    Time frame: At baseline

    Study of correlations from the outcomes measures 1, 2 and 3

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: MTA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2018
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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