Intestinal Microbiota, Tryptophan and Autism | NCT03751930

Studies
Intestinal Microbiota, Tryptophan and Autism

NCT03751930

Sponsor

University Hospital, Tours

Status

Completed

Last Update Posted

May 25, 2022Actual

Enrollment

66Actual

Phase

Not provided

Conditions

Autism Spectrum Disorder

Interventions

Samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-A01086-49	Other Identifier	IdRCB

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2019Actual

Primary Completion Date

Oct 28, 2021Actual

Completion Date

Oct 28, 2021Actual

First Submitted Date

Nov 21, 2018

First Submission Date that Met QC Criteria

Nov 21, 2018

First Posted Date

Nov 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2022

Last Update Posted Date

May 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Autism Spectre Disorders		Taken biological samples on patients with Autism Spectre Disorders	Other: Samples
Healthy volunteers		Taken biological samples on patients healthy volunteers	Other: Samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Samples	Other	Urinary and faecal samples	Healthy volunteers Patients with Autism Spectre Disorders

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

3-12 year old children with and without Autism Spectrum Disorders

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick EMOND, MD	University Hospital, Tours	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Child psychiatry department, University Hospital, Tours		Tours		37044	France
Clinical investigation center, University Hospital, Tours

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012494	Sampling Studies

Ancestor Terms

ID	Term
D016020	Epidemiologic Study Characteristics
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided