<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/NCT03270306</url>
  </required_header>
  <id_info>
    <org_study_id>2016.607</org_study_id>
    <nct_id>NCT03270306</nct_id>
  </id_info>
  <brief_title>Eating Behaviours, Diet and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders</brief_title>
  <official_title>Eating Behaviours, Diet Quality and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders and Typically Developing Children: a Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      This case-control study aims to compare the differences in eating behaviours, nutritional&#xD;
      status, diet quality and gastrointestinal (GI) health between Chinese children aged 3-6 years&#xD;
      with autism spectrum disorders (ASD) (n=65) and typically developing children (TDC) (n=65).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To compare the differences in eating behaviours, nutritional status, diet quality&#xD;
      and gastrointestinal (GI) health between Chinese children aged 3-6 years with autism spectrum&#xD;
      disorders (ASD) and typically developing children (TDC).&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. Children with ASD will show more problematic mealtime behaviours as represented by&#xD;
           higher scores of 'limited variety' and 'food refusal' domains of the BAMBI compared to&#xD;
           typically developing children&#xD;
&#xD;
        2. Children with ASD will have more GI symptoms, in particular constipation and diarrhea&#xD;
           compared to typically developing children&#xD;
&#xD;
        3. Children with ASD will have a lower ratio of Bacteroidetes to Firmicutes than the&#xD;
           typical control children&#xD;
&#xD;
        4. Children with ASD will have less desirable diet quality in terms of lower dietary index,&#xD;
           lower dietary diversity score and lower intake of fibre, iron, calcium, zinc and vitamin&#xD;
           C compared to typically developing children&#xD;
&#xD;
        5. A better diet quality will be associated with a more favourable gut microbial&#xD;
           composition in children with and without ASD&#xD;
&#xD;
      Design and subjects: Case-control study including 65 families with children of ASD and 65&#xD;
      families with TDC matched by child's age and sex.&#xD;
&#xD;
      Outcomes: The primary outcomes will be the difference in mean scores of 'limited variety' and&#xD;
      'food refusal' domains of the Chinese version of BAMBI between children with ASD and&#xD;
      typically developing children. The secondary outcomes will be the difference in the&#xD;
      occurrence of GI symptoms in terms of constipation and diarrhea, as well as the difference in&#xD;
      the gut microbiota profile in terms of the Bacteroidetes to Firmicutes ratio between children&#xD;
      with ASD and typically developing children. The tertiary outcome will be the difference in&#xD;
      the diet quality in terms of lower dietary index, lower dietary diversity score and lower&#xD;
      intake of fibre, iron, calcium, zinc and vitamin C in children with ASD and typically&#xD;
      developing children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 4, 2017</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mealtime behaviours</measure>
    <time_frame>baseline</time_frame>
    <description>Mealtime behaviours measured using the Chinese version of the Brief Autism Mealtime Behaviour Inventory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms</measure>
    <time_frame>baseline</time_frame>
    <description>Gastrointestinal symptoms measured using the Chinese version of the Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III (QPGS-RIII)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microbiota profile</measure>
    <time_frame>baseline</time_frame>
    <description>Gut microbiota profile measured using 16s sequencing</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Current diet quality</measure>
    <time_frame>baseline</time_frame>
    <description>Current diet quality measured using 3-day diet record</description>
  </other_outcome>
  <other_outcome>
    <measure>Usual diet quality</measure>
    <time_frame>baseline</time_frame>
    <description>Usual diet quality measured using food frequency questionnaire</description>
  </other_outcome>
  <enrollment type="Actual">130</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool sample and blood sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Sixty five families with children of ASD of Chinese origin aged between 3 and 6 years and&#xD;
        65 control families with typically developing children matched by child's age (within 6&#xD;
        months) and sex will be recruited through invitation letters using a convenience sampling&#xD;
        method in nurseries and kindergartens, in particular those with integrated programmes for&#xD;
        ASD children. Some other possible channels for recruiting families with ASD children will&#xD;
        include non-governmental organizations (NGOs) and some ASD family supporting groups.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Cases:&#xD;
&#xD;
        Families with their children diagnosed with ASD by paediatrician or clinical psychologist&#xD;
        according to the standard of the fourth or fifth edition of the Diagnostic and Statistical&#xD;
        Manual of Mental Disorders (DSM-IV or DSM-V) will be included.&#xD;
&#xD;
        Exclusion Criteria for Cases:&#xD;
&#xD;
        Families will be excluded if their children have the following conditions.&#xD;
&#xD;
          -  Diagnosed with chronic seizures&#xD;
&#xD;
          -  Suffered from recent infection 1-month prior to data and sample collection&#xD;
&#xD;
          -  With diseases or disorders that affect dietary/physical activity habits (e.g.&#xD;
             diabetes, cystic fibrosis, cerebral palsy)&#xD;
&#xD;
          -  Usage of antibiotics and antifungal medications 1-month prior to data and sample&#xD;
             collection&#xD;
&#xD;
          -  Currently participating or have recently participated (i.e. 1-month prior to data and&#xD;
             sample collection) in any trials or dietary intervention programs&#xD;
&#xD;
          -  With other major medical or psychological illness, as judged by the investigators as&#xD;
             ineligible to participate&#xD;
&#xD;
        Inclusion Criteria for Controls:&#xD;
&#xD;
        Families with typically developing children matched by child's age (i.e. within 6 months of&#xD;
        age) and sex will be included. Children without ASD, delays in motor and language&#xD;
        development, as well as behaviors as reported by their parents, and those do not have&#xD;
        first-degree relatives with ASD will be included. Parents will also be asked to complete&#xD;
        the Chinese validated version of Social Responsiveness Scale (SRS). For children who are&#xD;
        screened with positive results, they will be further assessed by a developmental&#xD;
        pediatrician to ascertain the autistic status. Only those who are screened negative, or&#xD;
        those who are screened positive but subsequently ascertained by the developmental&#xD;
        pediatrician being free from autistic symptoms will be included.&#xD;
&#xD;
        Exclusion Criteria for Controls:&#xD;
&#xD;
        The exclusion criteria will be same as those for the families with children of ASD.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>July 28, 2019</last_update_submitted>
  <last_update_submitted_qc>July 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Ruth Chan</investigator_full_name>
    <investigator_title>Senior Research Fellow</investigator_title>
  </responsible_party>
  <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>
    <mesh_term>Child Development Disorders, Pervasive</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/NCT03270306
org study id: 2016.607
nct id: NCT03270306
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This case-control study aims to compare the differences in eating behaviours, nutritional
      status, diet quality and gastrointestinal (GI) health between Chinese children aged 3-6 years
      with autism spectrum disorders (ASD) (n=65) and typically developing children (TDC) (n=65).
Objective: To compare the differences in eating behaviours, nutritional status, diet quality
      and gastrointestinal (GI) health between Chinese children aged 3-6 years with autism spectrum
      disorders (ASD) and typically developing children (TDC).

      Hypotheses:

        1. Children with ASD will show more problematic mealtime behaviours as represented by
           higher scores of 'limited variety' and 'food refusal' domains of the BAMBI compared to
           typically developing children

        2. Children with ASD will have more GI symptoms, in particular constipation and diarrhea
           compared to typically developing children

        3. Children with ASD will have a lower ratio of Bacteroidetes to Firmicutes than the
           typical control children

        4. Children with ASD will have less desirable diet quality in terms of lower dietary index,
           lower dietary diversity score and lower intake of fibre, iron, calcium, zinc and vitamin
           C compared to typically developing children

        5. A better diet quality will be associated with a more favourable gut microbial
           composition in children with and without ASD

      Design and subjects: Case-control study including 65 families with children of ASD and 65
      families with TDC matched by child's age and sex.

      Outcomes: The primary outcomes will be the difference in mean scores of 'limited variety' and
      'food refusal' domains of the Chinese version of BAMBI between children with ASD and
      typically developing children. The secondary outcomes will be the difference in the
      occurrence of GI symptoms in terms of constipation and diarrhea, as well as the difference in
      the gut microbiota profile in terms of the Bacteroidetes to Firmicutes ratio between children
      with ASD and typically developing children. The tertiary outcome will be the difference in
      the diet quality in terms of lower dietary index, lower dietary diversity score and lower
      intake of fibre, iron, calcium, zinc and vitamin C in children with ASD and typically
      developing children.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Mealtime behaviours
time frame: baseline
description: Mealtime behaviours measured using the Chinese version of the Brief Autism Mealtime Behaviour Inventory
measure: Gastrointestinal symptoms
time frame: baseline
description: Gastrointestinal symptoms measured using the Chinese version of the Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III (QPGS-RIII)
measure: Gut microbiota profile
time frame: baseline
description: Gut microbiota profile measured using 16s sequencing
measure: Current diet quality
time frame: baseline
description: Current diet quality measured using 3-day diet record
measure: Usual diet quality
time frame: baseline
description: Usual diet quality measured using food frequency questionnaire
Stool sample and blood sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Ruth Chan
investigator title: Senior Research Fellow
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive