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Trial record 38 of 1484 for:    child psychiatry

Intestinal Microbiota, Tryptophan and Autism (MTA)

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ClinicalTrials.gov Identifier: NCT03751930
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

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.


Condition or disease Intervention/treatment
Autism Spectrum Disorder Other: Samples

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intestinal Microbiota, Tryptophan and Autism
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tryptophan

Group/Cohort Intervention/treatment
Patients with Autism Spectre Disorders
Taken biological samples on patients with Autism Spectre Disorders
Other: Samples
Urinary and faecal samples

Healthy volunteers
Taken biological samples on patients healthy volunteers
Other: Samples
Urinary and faecal samples




Primary Outcome Measures :
  1. Urinary concentrations of tryptophan metabolites [ Time Frame: At baseline ]
    Quantification by High-Performance Liquid Chromatography and Mass Spectrometry

  2. Faecal concentrations of tryptophan metabolites [ Time Frame: At baseline ]
    Quantification by using High-Performance Liquid Chromatography and Mass Spectrometry


Secondary Outcome Measures :
  1. Characterization of gut microbiota [ Time Frame: At baseline ]
    Characterization by 16S ribosomal RNA sequencing

  2. Correlation of metabolic profiles of tryptophan and microbiotic profiles [ Time Frame: At baseline ]
    Study of correlations from the outcomes measures 1, 2 and 3


Biospecimen Retention:   Samples Without DNA
Urinary and faecal samples


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
3-8 year old children with and without Autism Spectrum Disorders
Criteria

Inclusion Criteria (patient):

  • 3-8 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 within 6 days before inclusion and until biological samples are collected

Inclusion Criteria (healthy volunteer):

  • 3-8 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751930


Contacts
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Contact: Patrick EMOND, MD 0247474722 ext +33 emond@univ-tours.fr
Contact: Frédérique BONNET-BRILHAULT, MD-PhD 0247478412 ext +33

Locations
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France
Child psychiatry department, University Hospital, Tours Not yet recruiting
Tours, France, 37044
Contact: Frédérique BONNET-BRILHAULT, MD-PhD         
Principal Investigator: Frédérique BONNET-BRILHAULT, MD-PhD         
Clinical investigation center, University Hospital, Tours Recruiting
Tours, France, 37044
Contact: Valérie GISSOT, MD         
Principal Investigator: Valérie GISSOT, MD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Study Director: Patrick EMOND, MD University Hospital, Tours

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03751930     History of Changes
Other Study ID Numbers: DR180136
2018-A01086-49 ( Other Identifier: IdRCB )
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Tours:
Autism Spectrum Disorder
Tryptophan metabolism
Gut microbiota

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Tryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs