Exploring gene and environment interactions in neurodevelopmental disorders
A Novel Multi-dimensional Prospective Study of the Gut-brain Axis Through Metabolic MRI, Metabolomics and Gut Microbiome to Discover Gene-microenvironment Interactions in Neurodevelopmental Disorders
This study is trying to see how genes and the environment affect people with autism and ADHD by collecting different types of data over a few years to find ways to improve their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT04878575 on ClinicalTrials.gov |
What this trial studies
This project aims to create a comprehensive database that integrates clinical, behavioral, neurocognitive, brain imaging, metabolomic, and microbiome data for individuals diagnosed with autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD). By examining the gut-brain axis and identifying biomarkers associated with these disorders, the study seeks to uncover common and unique factors that contribute to their development. The research will involve repeated assessments over a period of 2 to 3 years to track changes and identify potential biological treatments that may mitigate cognitive impairments. This multi-dimensional approach is novel as it combines various methodologies to enhance our understanding of these neurodevelopmental disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5 to 18 diagnosed with ASD or ADHD by certified child psychiatrists, with both parents being Han Chinese.
Not a fit: Patients with comorbid psychiatric or neurological disorders, or those with a family history of ASD, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of biomarkers and biological treatments that improve outcomes for patients with ASD and ADHD.
How similar studies have performed: While there have been studies on ASD and ADHD separately, this integrated approach is relatively novel and has not been extensively tested in prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of autism spectrum disorder or attention-deficit hyperactivity disorder defined by the DSM-5 criteria, made by board-certificated child psychiatrists * Ages range from 5 to 18 * Both parents are Han Chinese * Subjects and their parents consented to have repeated assessments at 2 to 3 years later Exclusion Criteria: * Comorbidity with DSM-5 diagnoses of ADHD (TDC group), ASD (ADHD and TDC groups), schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorders, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use * Comorbidity with neurological or systemic disorders * Having a first degree relative who may have ASD based on family history method assessment (ADHD and TDC groups)
Where this trial is running
Taipei
- National Taiwan Univeristy Hospital — Taipei, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.