Intestinal Microbiota, Tryptophan and Autism (MTA)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Other: Samples

Study type: Observational

Funder types: Other

Identifiers

NCT03751930

DR180136

2018-A01086-49 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

66 participants in 2 patient groups

Patients with Autism Spectre Disorders

Description:

Taken biological samples on patients with Autism Spectre Disorders

Treatment:

Other: Samples

Healthy volunteers

Description:

Taken biological samples on patients healthy volunteers

Treatment:

Other: Samples