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Completed

NCT Number: NCT03270306

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

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).

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese University of Hong Kong

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mealtime behaviours

    Time frame: baseline

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

Secondary outcomes

  1. Gastrointestinal symptoms

    Time frame: baseline

    Gastrointestinal symptoms measured using the Chinese version of the Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III (QPGS-RIII)

  2. Gut microbiota profile

    Time frame: baseline

    Gut microbiota profile measured using 16s sequencing

Other outcomes

  1. Current diet quality

    Time frame: baseline

    Current diet quality measured using 3-day diet record

  2. Usual diet quality

    Time frame: baseline

    Usual diet quality measured using food frequency questionnaire

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Eating Behaviours, Diet Quality and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders and Typically Developing Children: a Case-control Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 1, 2017
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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