- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03270306
Eating Behaviours, Diet and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders
Eating Behaviours, Diet Quality and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders and Typically Developing Children: a Case-control Study
Study Overview
Status
Conditions
Detailed Description
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:
- 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
- Children with ASD will have more GI symptoms, in particular constipation and diarrhea compared to typically developing children
- Children with ASD will have a lower ratio of Bacteroidetes to Firmicutes than the typical control children
- 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
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Hong Kong, China
- Chinese University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for Cases:
Families with their children diagnosed with ASD by paediatrician or clinical psychologist according to the standard of the fourth or fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV or DSM-V) will be included.
Exclusion Criteria for Cases:
Families will be excluded if their children have the following conditions.
- Diagnosed with chronic seizures
- Suffered from recent infection 1-month prior to data and sample collection
- With diseases or disorders that affect dietary/physical activity habits (e.g. diabetes, cystic fibrosis, cerebral palsy)
- Usage of antibiotics and antifungal medications 1-month prior to data and sample collection
- Currently participating or have recently participated (i.e. 1-month prior to data and sample collection) in any trials or dietary intervention programs
- With other major medical or psychological illness, as judged by the investigators as ineligible to participate
Inclusion Criteria for Controls:
Families with typically developing children matched by child's age (i.e. within 6 months of age) and sex will be included. Children without ASD, delays in motor and language development, as well as behaviors as reported by their parents, and those do not have first-degree relatives with ASD will be included. Parents will also be asked to complete the Chinese validated version of Social Responsiveness Scale (SRS). For children who are screened with positive results, they will be further assessed by a developmental pediatrician to ascertain the autistic status. Only those who are screened negative, or those who are screened positive but subsequently ascertained by the developmental pediatrician being free from autistic symptoms will be included.
Exclusion Criteria for Controls:
The exclusion criteria will be same as those for the families with children of ASD.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mealtime behaviours
Time Frame: baseline
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Mealtime behaviours measured using the Chinese version of the Brief Autism Mealtime Behaviour Inventory
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastrointestinal symptoms
Time Frame: baseline
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Gastrointestinal symptoms measured using the Chinese version of the Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III (QPGS-RIII)
|
baseline
|
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Gut microbiota profile
Time Frame: baseline
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Gut microbiota profile measured using 16s sequencing
|
baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Current diet quality
Time Frame: baseline
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Current diet quality measured using 3-day diet record
|
baseline
|
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Usual diet quality
Time Frame: baseline
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Usual diet quality measured using food frequency questionnaire
|
baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016.607
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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