Clinical trial NCT03751930: Intestinal Microbiota, Tryptophan and Autism
Official title: Intestinal Microbiota, Tryptophan and Autism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Tryptophan metabolism
Gut microbiota
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3-12 year old children with and without Autism Spectrum Disorders

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.

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

Primary outcomes:
measure: Urinary concentrations of tryptophan metabolites
timeFrame: At baseline
measure: Faecal concentrations of tryptophan metabolites
timeFrame: At baseline
Secondary outcomes:
measure: Characterization of gut microbiota
timeFrame: At baseline
measure: Correlation of metabolic profiles of tryptophan and microbiotic profiles
timeFrame: At baseline
Other outcomes:
Locations:
city: Tours
country: France
facility: Child psychiatry department, University Hospital, Tours
city: Tours
country: France
facility: Clinical investigation center, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Patrick EMOND, MD
role: STUDY_DIRECTOR
References: