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CompletedNCT03751930MTAUpdated May 25, 2022

Intestinal Microbiota, Tryptophan and Autism

An observational study in Autism Spectrum Disorder, sponsored by University Hospital, Tours. Completed at 2 sites in France. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-25.

Sponsored by University Hospital, Tours · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
3 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • Autism Spectrum Disorder
  • Tryptophan metabolism
  • Gut microbiota
03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 66 is below the median of 102 across 267 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with Autism Spectre Disorders

    Taken biological samples on patients with Autism Spectre Disorders

    Other: Samples

  • Healthy volunteers

    Taken biological samples on patients healthy volunteers

    Other: Samples

Interventions

  • OtherSamples

    Urinary and faecal samples

06

What researchers measure

Primary outcomes

  1. Urinary concentrations of tryptophan metabolites

    Quantification by High-Performance Liquid Chromatography and Mass Spectrometry

    Time frame: At baseline

  2. Faecal concentrations of tryptophan metabolites

    Quantification by using High-Performance Liquid Chromatography and Mass Spectrometry

    Time frame: At baseline

Secondary outcomes

  1. Characterization of gut microbiota

    Characterization by 16S ribosomal RNA sequencing

    Time frame: At baseline

  2. Correlation of metabolic profiles of tryptophan and microbiotic profiles

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

    Time frame: At baseline

07

Study locations

2 sites
  • Child psychiatry department, University Hospital, Tours
    Tours, 37044, France
  • Clinical investigation center, University Hospital, Tours
    Tours, 37044, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03751930
Lead sponsor
University Hospital, Tours
Responsible party
Sponsor
First posted
Nov 23, 2018
Start date
Jan 2, 2019
Primary completion
Oct 28, 2021
Completion
Oct 28, 2021
Last update
May 25, 2022

Study contacts

Patrick EMOND, MD
study director · University Hospital, Tours

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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