<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03751930</url>
  </required_header>
  <id_info>
    <org_study_id>DR180136</org_study_id>
    <secondary_id>2018-A01086-49</secondary_id>
    <nct_id>NCT03751930</nct_id>
  </id_info>
  <brief_title>Intestinal Microbiota, Tryptophan and Autism</brief_title>
  <acronym>MTA</acronym>
  <official_title>Intestinal Microbiota, Tryptophan and Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social&#xD;
      communication and behavioral adaptation. Currently, the diagnosis of Autism Spectrum Disorder&#xD;
      is based on a clinical examination that is performed classically during the first three years&#xD;
      of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to&#xD;
      diagnose and manage.&#xD;
&#xD;
      The overall goal of this project is the identification of metabolic biomarkers based on&#xD;
      clinical profile. The best characterization of physiopathological pathways will ultimately&#xD;
      allow the identification of subgroups of subjects and facilitate the development of targeted&#xD;
      therapeutics.&#xD;
&#xD;
      The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in&#xD;
      Autism Spectrum Disorder via the gut microbiota.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social&#xD;
      communication and behavioral adaptation. In France, Autism Spectrum Disorderaffects about 1&#xD;
      in 100 people according to international criteria and is diagnosed in early childhood.&#xD;
      Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that&#xD;
      is performed classically during the first three years of life. The heterogeneity of the&#xD;
      disorders occurring in autism make pathologies difficult to diagnose and manage.&#xD;
&#xD;
      The overall goal of this project is the identification of metabolic biomarkers based on&#xD;
      clinical profile (based on behavioral and cognitive markers). The best characterization of&#xD;
      physiopathological pathways (from the molecular scale to the phenotypic scale) will&#xD;
      ultimately allow the identification of subgroups of subjects and facilitate the development&#xD;
      of targeted therapeutics.&#xD;
&#xD;
      The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in&#xD;
      Autism Spectrum Disorder via the gut microbiota.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">October 28, 2021</completion_date>
  <primary_completion_date type="Actual">October 28, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary concentrations of tryptophan metabolites</measure>
    <time_frame>At baseline</time_frame>
    <description>Quantification by High-Performance Liquid Chromatography and Mass Spectrometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Faecal concentrations of tryptophan metabolites</measure>
    <time_frame>At baseline</time_frame>
    <description>Quantification by using High-Performance Liquid Chromatography and Mass Spectrometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterization of gut microbiota</measure>
    <time_frame>At baseline</time_frame>
    <description>Characterization by 16S ribosomal RNA sequencing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of metabolic profiles of tryptophan and microbiotic profiles</measure>
    <time_frame>At baseline</time_frame>
    <description>Study of correlations from the outcomes measures 1, 2 and 3</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Patients with Autism Spectre Disorders</arm_group_label>
    <description>Taken biological samples on patients with Autism Spectre Disorders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Taken biological samples on patients healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Samples</intervention_name>
    <description>Urinary and faecal samples</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Patients with Autism Spectre Disorders</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urinary and faecal samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        3-12 year old children with and without Autism Spectrum Disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (patient):&#xD;
&#xD;
          -  3-12 year old child&#xD;
&#xD;
          -  Diagnosis of Autism Spectrum Disorders according to the DSM-5 (2013), invasive&#xD;
             developmental disorder according to the ICD-10 (1993) or Autism Spectrum Disorders&#xD;
             according to ICD-11 (2018)&#xD;
&#xD;
          -  Affiliate or beneficiary of a social security scheme&#xD;
&#xD;
          -  Consent signed by at least one of the parents&#xD;
&#xD;
        Exclusion Criteria (patient):&#xD;
&#xD;
          -  Chronic inflammatory pathology&#xD;
&#xD;
          -  Probiotic intake&#xD;
&#xD;
          -  Taking medication (except melatonin) within 6 days before inclusion and until&#xD;
             biological samples are collected&#xD;
&#xD;
        Inclusion Criteria (healthy volunteer):&#xD;
&#xD;
          -  3-12 year old child&#xD;
&#xD;
          -  Affiliate or beneficiary of a social security scheme&#xD;
&#xD;
          -  Consent signed by both parents&#xD;
&#xD;
        Exclusion Criteria (healthy volunteer):&#xD;
&#xD;
          -  Chronic inflammatory pathology&#xD;
&#xD;
          -  Digestive pathology&#xD;
&#xD;
          -  Probiotic intake&#xD;
&#xD;
          -  Taking medication within 6 days before inclusion and until biological samples are&#xD;
             collected&#xD;
&#xD;
          -  Personal and / or family history of neurological disease, epilepsy, psychiatric&#xD;
             disorder, neurodevelopmental disorder, language disorder, overdrive, intellectual&#xD;
             disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick EMOND, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Tours</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Child psychiatry department, University Hospital, Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical investigation center, University Hospital, Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autism Spectrum Disorder</keyword>
  <keyword>Tryptophan metabolism</keyword>
  <keyword>Gut microbiota</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03751930
org study id: DR180136
secondary id: 2018-A01086-49
nct id: NCT03751930
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Urinary concentrations of tryptophan metabolites
time frame: At baseline
description: Quantification by High-Performance Liquid Chromatography and Mass Spectrometry
measure: Faecal concentrations of tryptophan metabolites
time frame: At baseline
description: Quantification by using High-Performance Liquid Chromatography and Mass Spectrometry
measure: Characterization of gut microbiota
time frame: At baseline
description: Characterization by 16S ribosomal RNA sequencing
measure: Correlation of metabolic profiles of tryptophan and microbiotic profiles
time frame: At baseline
description: Study of correlations from the outcomes measures 1, 2 and 3
arm group label: Patients with Autism Spectre Disorders
description: Taken biological samples on patients with Autism Spectre Disorders
arm group label: Healthy volunteers
description: Taken biological samples on patients healthy volunteers
intervention type: Other
intervention name: Samples
description: Urinary and faecal samples
arm group label: Healthy volunteers
arm group label: Patients with Autism Spectre Disorders
Urinary and faecal samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick EMOND, MD
role: Study Director
affiliation: University Hospital, Tours
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder