AzTrials
AzTrials

AutismNCT04890717

Biomarkers for Autism and ADHD in Children

An observational study of Autism and ADHD, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Autism (ASD) is one of the frequent neurodevelopmental disorders that children would occur. Many studies have shown that individuals with Autism are more common to experience significant gastrointestinal problems than other individuals. Symptoms include constipation, diarrhea, abdominal pain and gastric reflux. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Autism, ADHD
How many people
320 participants
Where
1 siteHong Kong
Study dates
15 May 2021to 31 Dec 2024
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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Subjects include * suspected or confirmed cases of ASD and/or ADHD children (Case group), * typically developed siblings of suspected or confirmed cases of ASD and/or ADHD children (Sibling group), * parents of suspected or confirmed cases of ASD and/or ADHD children (Parent group) * typically developed children not related to the case group (Control Group).

Who may be able to join

  • Case group, Sibling group and Control group:
  • Children aged under 18 years old; and
  • The parents or legal guardian agree to hand in the stool samples of children; and agree to complete questionnaires; and
  • The parents or legal guardian agree to sign the informed consent form for the children
  • Parent group:
  • Their suspected or confirmed ASD or ADHD children participated in the study; and
  • Agree to hand in stool samples and complete questionnaires; and
  • Agree to sign the informed consent consent

Who cannot join

  • All groups:
  • Any subject taken probiotics, prebiotics, antibiotics 30 days before enrollment.
  • Subjects can be re-approached or join the study 30 days after taking probiotics, prebiotics, antibiotics.

Trial locations and contacts

1 site in 1 country.

Terence Yeung, Bsc contact

26373225

wanchunyeung@cuhk.edu.hk

Long Ip, Bsc contact

26373225

longip@cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • Prince of Wales Hospital

    Hong Kong

    Siew Chien Ng, PhD, 35053996, siewchienng@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Microbial Stool Biomarkers for Prediction of Autism and ADHD in Children

Autism (ASD) is one of the frequent neurodevelopmental disorders that children would occur. Many studies have shown that individuals with Autism are more common to experience significant gastrointestinal problems than other individuals. Symptoms include constipation, diarrhea, abdominal pain and gastric reflux. A recent study with 50 children with ASD, 50 children with other developmental disabilities and 50 healthy control children, it found that 70% of ASD children had presented with GI symptoms, compared with 42% of developmental disabilities children and 28% of developing children, it is believed that ASD children will have a distinctive microbial pattern in the stool.

Attention-deficit/hyperactivity disorder (ADHD) is another neurodevelopmental and neurobehavioral disorder. A study found that ADHD individuals experience significantly higher rate of stomach pain and bowel problems than other control individuals. It is suggested that the microbiota in the stool of ADHD children might be different. Genetic study also found that if a child has a sibling with ADHD, the risk of developing ADHD is three to four times higher than that of children with siblings without ADHD.

Read the detailed description

Autism Spectrum Disorder (ASD) was first developed by Kanner in 1943. In Hong Kong, a study showed that as many as 49 out of 10,000 children were diagnosed in Autism. ASD is one of the frequent neurodevelopmental disorders that children would occur. Many studies have shown that individuals with Autism are more common to experience significant gastrointestinal problems than other individuals. Symptoms include constipation, diarrhoea, abdominal pain and gastric reflux. In a study with 160 children with ASD, 59% had GI symptoms, including diarrhoea, unformed stool, constipation, bloating and gastroesophageal reflux (GERD). A study compared 51 ASD children, and 40 healthy control children found that 63% of ASD children had moderate or severe diarrhoea and constipation symptoms. In contrast, only 2% of control children had such experience. Similarly, a study of 150 children, with 50 children with ASD, 50 children with other developmental disabilities and 50 healthy control children, it found that 70% of ASD children had presented with GI symptoms, compared with 42% of developmental disabilities children and 28% of developing children. Other study stated that such untreated GI symptoms might worsen the behavioural issue of ASD children. As there is a strong relationship between ASD children and GI symptoms, it is believed that ASD children will have a distinctive microbial pattern in the stool.

Attention-deficit/hyperactivity disorder (ADHD) is another neurodevelopmental and neurobehavioral disorder. In Hong Kong, there were 8.9% of ADHD children among Primary one Chinese schoolboys. A large study (N=6483) found that ADHD individuals experience a significantly higher rate of stomach pain and bowel problems than other control individuals. McKeown did another study also reported that ADHD children were more likely to experience constipation and stool incontinence than normal healthy children. In one study that compared the Gastrointestinal Severity Index scoring between children with ADHD and healthy subjects, children with ADHD had significantly higher mean and scored higher in constipation, diarrhoea and flatulence variables. As the findings of ADHD individuals and gastrointestinal symptoms are closely associated, the microbiota in the stool might be different from normal children without ADHD.

Accumulating evidence implicated gut microbiota play a role in autism spectrum disorder (ASD). A huge community of microorganisms in the gastrointestinal (GI) tract impacts the development and function of the immune, metabolic, and nervous systems via the gut-brain axis. Majority of studies shown the diversity of gut microbiota changed in children with ASD compared with that of typically developing (TD) children, suggesting that the overall microbiota composition altered in ASD. Differences were observed between ASD and TD when comparing the abundance of bacteria in phyla and species level. Potential faecal bacteria biomarkers in the stool of children with ASD will be a useful non-invasive tool for early detection that will benefit more children with suspected conditions.

The microbiota was involved in many aspects of behaviour was confirmed in animal studies and human trial but it remains unclear whether gut microbiota recover in children with ASD after the intervention. Genetic research has revealed that if a child has a sibling with ADHD, the risk of developing ADHD is three to four times higher than that of children with siblings without ADHD.

Besides, previous studies showed that maternal unhealthy diet, tobacco use, and the harmful use of alcohol during pregnancy induce a shift in microbial ecology that negatively impacts offspring social behavior and has a fundamental role in the etiopathogenesis of ASD and ADHD. In some cases, children who have experienced stress, emotional abuse and violence are more prone to ADHD behaviour.

Conditions
Autism, ADHD
Medical subject headings
Autistic Disorder, Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04890717
Study groupRoleWhat they receive
ASD and/or ADHD children (Case group)Suspected or confirmed cases of ASD and/or ADHD children (Case group); no intervention(s) to be administered.
Parent groupParents of suspected or confirmed cases of ASD and/or ADHD children; no intervention(s) to be administered.
Sibling groupTypically developed siblings of suspected or confirmed cases of ASD and/or ADHD children; no intervention(s) to be administered.
Control groupTypically developed children not related to the case group ; no intervention(s) to be administered.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To identify the microbial species in stool in suspected and confirmed ASD and/or ADHD children

    Random Forest (RF) will be used for identifying the species of the biomarkers. The importance value of each species to the classification model will be evaluated by recursive feature elimination.

    Measured: 6 months

Secondary outcomes (5)
  1. To confirm different microbial species in stool in suspected and confirmed ASD and/or ADHD children across 2 years

    Different species will be compared in terms of binary classifiers with Area Under the Curve (AUC) in Receiver Operating Characteristic (ROC) curves.

    Measured: 2 years

  2. To confirm different microbial species in stool at different age groups in suspected and confirmed ADS and/or ADHD children across 2 years

    Different species will be compared in terms of binary classifiers with Area Under the Curve (AUC) in Receiver Operating Characteristic (ROC) curves.

    Measured: 2 years

  3. To correlate the changes in microbial species in stool with different diet habits in ASD and/or ADHD children across 2 years

    Correlation statistical method will be used

    Measured: 2 years

  4. To correlate the changes in microbial species in stool between the suspected and confirmed ASD and/or ADHD children with their siblings, parent or typically developed children at baseline

    Correlation statistical method will be used

    Measured: baseline

  5. To correlate the changes in microbial species in stool with different food additives levels in all subject groups at baseline

    Correlation statistical method will be used

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2021
  2. Study start15 May 2021
  3. Primary completion14 May 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04890717
Sponsor's protocol ID
Mic_ASDADHD
Status last verified
Feb 2023
First submitted
9 May 2021
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Autism and ADHD, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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 Hong Kong. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Terence Yeung, Bsc (26373225, wanchunyeung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To identify the microbial species in stool in suspected and confirmed ASD and/or ADHD children (time frame: 6 months). 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 8 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in