Eating Behaviours, Diet and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders

NCT03270306 | Completed

• 1 other identifier: 2016.607
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Mealtime behaviours

  Mealtime behaviours measured using the Chinese version of the Brief Autism Mealtime Behaviour Inventory

  baseline

Secondary Outcomes (2)

• Gastrointestinal symptoms

  baseline

• Gut microbiota profile

  baseline

Other Outcomes (2)

• Current diet quality

  baseline

• Usual diet quality

  baseline

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Sixty five families with children of ASD of Chinese origin aged between 3 and 6 years and 65 control families with typically developing children matched by child's age (within 6 months) and sex will be recruited through invitation letters using a convenience sampling method in nurseries and kindergartens, in particular those with integrated programmes for ASD children. Some other possible channels for recruiting families with ASD children will include non-governmental organizations (NGOs) and some ASD family supporting groups.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample and blood sample

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 1, 2017
• Study Start: November 4, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

CN (1)