Biomarkers for Autism and ADHD in Children

NCT04890717 | Unknown

• 1 other identifier: Mic_ASDADHD
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism; ADHD

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (5)

• To confirm different microbial species in stool in suspected and confirmed ASD and/or ADHD children across 2 years

  2 years

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

  2 years

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

  2 years

• 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

  baseline

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

  baseline

Study Arms (4)

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 group

Parents of suspected or confirmed cases of ASD and/or ADHD children; no intervention(s) to be administered.

Sibling group

Typically developed siblings of suspected or confirmed cases of ASD and/or ADHD children; no intervention(s) to be administered.

Control group

Typically developed children not related to the case group ; no intervention(s) to be administered.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

stool

MeSH Terms

Conditions

Autistic Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Study Officials

• Siew Ng, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terence Yeung, Bsc

CONTACT

26373225; wanchunyeung@cuhk.edu.hk

Long Ip, Bsc

CONTACT

26373225; longip@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 18, 2021
• Study Start: May 15, 2021
• Primary Completion: May 14, 2024
• Study Completion: December 31, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)