NCT03751930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

November 21, 2018

Last Update Submit

May 24, 2022

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum DisorderTryptophan metabolismGut microbiota

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Characterization of gut microbiota

    At baseline

  • Correlation of metabolic profiles of tryptophan and microbiotic profiles

    At baseline

Study Arms (2)

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

SamplesOTHER

Urinary and faecal samples

Healthy volunteersPatients with Autism Spectre Disorders

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Chronic inflammatory pathology
  • Probiotic intake
  • year old child
  • Affiliate or beneficiary of a social security scheme
  • Consent signed by both parents
  • Chronic inflammatory pathology
  • Digestive pathology
  • Probiotic intake
  • Personal and / or family history of neurological disease, epilepsy, psychiatric disorder, neurodevelopmental disorder, language disorder, overdrive, intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Child psychiatry department, University Hospital, Tours

Tours, 37044, France

Location

Clinical investigation center, University Hospital, Tours

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinary and faecal samples

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Sampling Studies

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Patrick EMOND, MD

    University Hospital, Tours

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 23, 2018

Study Start

January 2, 2019

Primary Completion

October 28, 2021

Study Completion

October 28, 2021

Last Updated

May 25, 2022

Record last verified: 2022-05

Locations

FR(2)