<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/NCT01675414</url>
  </required_header>
  <id_info>
    <org_study_id>Grant 2037</org_study_id>
    <nct_id>NCT01675414</nct_id>
  </id_info>
  <brief_title>Understanding Gastrointestinal Conditions in Children With Autism Spectrum Disorder (ASD)</brief_title>
  <official_title>Understanding Gastrointestinal Conditions in Children With ASD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Autism Speaks</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to help us learn if children with Autism Spectrum&#xD;
      Disorder (ASD) have gastrointestinal (stomach and intestine) problems more frequently than&#xD;
      children without ASD do. The investigators hope to learn if children with ASD and&#xD;
      gastrointestinal (GI) disorders have certain Problem Behaviors (PB), such as self-injury and&#xD;
      aggression, more than children with ASD but no GI disorders do. The investigators want to&#xD;
      learn if the Gastrointestinal Symptoms Questionnaire (GIQ) can help us tell which children&#xD;
      with ASD also have gastrointestinal disorders.&#xD;
&#xD;
      Hypothesis 1: Children with ASD exhibit high rates of symptomatic GI dysfunction that are not&#xD;
      identified by current diagnostic evaluation.&#xD;
&#xD;
      Hypothesis 2: Painful or discomfort-causing gastrointestinal dysfunctions contribute to an&#xD;
      elevated incidence or severity of PB in an identifiable subpopulation of PB-expressing&#xD;
      children. The investigators anticipate that the proposed study will raise the standard of&#xD;
      medical care for children with ASD by improving current methods of identifying GI dysfunction&#xD;
      and determining whether there is a significant relationship between GI dysfunction and PB in&#xD;
      this population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">February 2011</completion_date>
  <primary_completion_date type="Actual">June 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>diagnosis of active gastrointestinal disorder/dysfunction based on the medical history reviewed by and the physical examination performed by a pediatric gastroenterologist</measure>
    <time_frame>6 months after initial evaluation by pediatric gastroenterologist</time_frame>
  </primary_outcome>
  <enrollment type="Actual">131</enrollment>
  <condition>Gastrointestinal Disorders</condition>
  <condition>Autism Spectrum Disorders</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>evaluation visit by a pediatric gastroenterologist</intervention_name>
    <description>medical history, physical exam completed by pediatric gastroenterologist</description>
    <other_name>autism</other_name>
    <other_name>ASD</other_name>
    <other_name>pediatric</other_name>
    <other_name>gastrointestinal</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        131 nonselected subjects with ASD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children who are ATN Registry subjects between 2 and 17 years old (inclusive)&#xD;
&#xD;
          -  Meet criteria for an ASD according to the diagnostic measures Autism Diagnostic&#xD;
             Observation Schedule (ADOS) and DSM-IV Symptom Checklist, which were conducted at an&#xD;
             established ATN center within the last 18 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnoses of Rett Syndrome, Childhood Disintegrative Disorder, or other genetic&#xD;
             disorders (e.g. Fragile X, Down syndrome, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harland S Winter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LADDERS, Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02412</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>April 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 29, 2012</last_update_submitted>
  <last_update_submitted_qc>August 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Harland S. Winter, MD</investigator_full_name>
    <investigator_title>Director, Pediatric Inflammatory Bowel Disease Center</investigator_title>
  </responsible_party>
  <keyword>ASD</keyword>
  <keyword>autism</keyword>
  <keyword>gastrointestinal</keyword>
  <keyword>gastrointestinal conditions in children with ASD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
    <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/NCT01675414
org study id: Grant 2037
nct id: NCT01675414
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this research study is to help us learn if children with Autism Spectrum
      Disorder (ASD) have gastrointestinal (stomach and intestine) problems more frequently than
      children without ASD do. The investigators hope to learn if children with ASD and
      gastrointestinal (GI) disorders have certain Problem Behaviors (PB), such as self-injury and
      aggression, more than children with ASD but no GI disorders do. The investigators want to
      learn if the Gastrointestinal Symptoms Questionnaire (GIQ) can help us tell which children
      with ASD also have gastrointestinal disorders.

      Hypothesis 1: Children with ASD exhibit high rates of symptomatic GI dysfunction that are not
      identified by current diagnostic evaluation.

      Hypothesis 2: Painful or discomfort-causing gastrointestinal dysfunctions contribute to an
      elevated incidence or severity of PB in an identifiable subpopulation of PB-expressing
      children. The investigators anticipate that the proposed study will raise the standard of
      medical care for children with ASD by improving current methods of identifying GI dysfunction
      and determining whether there is a significant relationship between GI dysfunction and PB in
      this population.
observational model: Cohort
measure: diagnosis of active gastrointestinal disorder/dysfunction based on the medical history reviewed by and the physical examination performed by a pediatric gastroenterologist
time frame: 6 months after initial evaluation by pediatric gastroenterologist
intervention type: Other
intervention name: evaluation visit by a pediatric gastroenterologist
description: medical history, physical exam completed by pediatric gastroenterologist
other name: autism
other name: ASD
other name: pediatric
other name: gastrointestinal
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Harland S Winter, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Harland S. Winter, MD
investigator title: Director, Pediatric Inflammatory Bowel Disease Center
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder