Autism Spectrum DisorderNCT03270306
Eating Behaviours, Diet and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders
An observational study of Autism Spectrum Disorder, run by Chinese University of Hong Kong at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2017to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
- The exclusion criteria will be same as those for the families with children of ASD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eating Behaviours, Diet Quality and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders and Typically Developing Children: a Case-control Study
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).
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Mealtime behaviours
Mealtime behaviours measured using the Chinese version of the Brief Autism Mealtime Behaviour Inventory
Measured: baseline
Secondary outcomes (2)
Gastrointestinal symptoms
Gastrointestinal symptoms measured using the Chinese version of the Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III (QPGS-RIII)
Measured: baseline
Gut microbiota profile
Gut microbiota profile measured using 16s sequencing
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start4 Nov 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270306
- Sponsor's protocol ID
- 2016.607
- Status last verified
- Jul 2019
- First submitted
- 29 Aug 2017
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Behaviours, Diet Quality and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders and Typically Developing Children: a Case-control Study
- ClinicalTrials.gov ID
- NCT03270306
- Acronym / sponsor ID
- 2016.607
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 4 Nov 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mealtime behaviours
Time frame: baseline
Mealtime behaviours measured using the Chinese version of the Brief Autism Mealtime Behaviour Inventory
2 secondary outcomes
Gastrointestinal symptoms
Time frame: baseline
Gut microbiota profile
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mealtime behaviours (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.