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Intestinal Microbiota, Tryptophan and Autism

Intestinal Microbiota, Tryptophan and Autism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03751930
Acronym
MTA
Enrollment
66
Registered
2018-11-23
Start date
2019-01-02
Completion date
2021-10-28
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder, Tryptophan metabolism, Gut microbiota

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.

Interventions

OTHERSamples

Urinary and faecal samples

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Urinary concentrations of tryptophan metabolitesAt baselineQuantification by High-Performance Liquid Chromatography and Mass Spectrometry
Faecal concentrations of tryptophan metabolitesAt baselineQuantification by using High-Performance Liquid Chromatography and Mass Spectrometry

Secondary

MeasureTime frameDescription
Characterization of gut microbiotaAt baselineCharacterization by 16S ribosomal RNA sequencing
Correlation of metabolic profiles of tryptophan and microbiotic profilesAt baselineStudy of correlations from the outcomes measures 1, 2 and 3

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026