Intestinal Microbiota, Tryptophan and Autism

Autism Spectrum Disorder Clinical Trial

— MTA  

Official title:

Intestinal Microbiota, Tryptophan and Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751930
• Other study ID #: DR180136
• Secondary ID: 2018-A01086-49
• Status: Completed
• Start date: January 2, 2019
• Est. completion date: October 28, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• Samples
Urinary and faecal samples

Locations

Country	Name	City	State
France	Child psychiatry department, University Hospital, Tours	Tours
France	Clinical investigation center, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary concentrations of tryptophan metabolites	Quantification by High-Performance Liquid Chromatography and Mass Spectrometry	At baseline
Primary	Faecal concentrations of tryptophan metabolites	Quantification by using High-Performance Liquid Chromatography and Mass Spectrometry	At baseline
Secondary	Characterization of gut microbiota	Characterization by 16S ribosomal RNA sequencing	At baseline
Secondary	Correlation of metabolic profiles of tryptophan and microbiotic profiles	Study of correlations from the outcomes measures 1, 2 and 3	At baseline