Intestinal Microbiota, Tryptophan and Autism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intestinal Microbiota, Tryptophan and Autism

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: Samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Autism Spectre Disorders<br>Taken biological samples on patients with Autism Spectre Disorders | Other: Samples<br>* Urinary and faecal samples<br>|
| Healthy volunteers<br>Taken biological samples on patients healthy volunteers | Other: Samples<br>* Urinary and faecal samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of gut microbiota | Characterization by 16S ribosomal RNA sequencing | At baseline | 
| Correlation of metabolic profiles of tryptophan and microbiotic profiles | Study of correlations from the outcomes measures 1, 2 and 3 | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorder, Tryptophan metabolism, Gut microbiota