Autism Spectrum Disorder Clinical Trial
Official title:
Eating Behaviours, Diet Quality and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders and Typically Developing Children: a Case-control Study
NCT number | NCT03270306 |
Other study ID # | 2016.607 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 4, 2017 |
Est. completion date | May 31, 2019 |
Verified date | July 2019 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 130 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Chinese University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Current diet quality | Current diet quality measured using 3-day diet record | baseline | |
Other | Usual diet quality | Usual diet quality measured using food frequency questionnaire | baseline | |
Primary | Mealtime behaviours | Mealtime behaviours measured using the Chinese version of the Brief Autism Mealtime Behaviour Inventory | baseline | |
Secondary | Gastrointestinal symptoms | Gastrointestinal symptoms measured using the Chinese version of the Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III (QPGS-RIII) | baseline | |
Secondary | Gut microbiota profile | Gut microbiota profile measured using 16s sequencing | baseline |
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