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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

This project is the first involving the two most common neurodevelopmental disorders, ASD and ADHD, as well as TDC to establish a multi-dimensional database (clinic, behavior, neurocognitive function, brain imaging, metabolomics, and microbiome) using the same methodology. Based on this integrated multi-dimensional databank, we anticipate exploring metabolic flows of the gut-brain axis during brain development and identifying the common and unique biomarkers of ASD and ADHD and high-risk materials related to their functions and the underlying mechanism. Moreover, distinguishing the characteristics of the gut microbiota, gastrointestinal disorders, and microbial flora dysbiosis also helps us, in turn, to accelerate the process of identifying biological treatments that can interfere or slow down the severity of cognitive impairments in neurodevelopmental disorders. Eventually, we anticipate finding the clinical and neurocognitive measures related to the direct or indirect influence of gut-brain signaling. Our findings are anticipated to improve the knowledge about neurodevelopmental disorders, enhance developing early detection, diagnosis, and treatment for ASD and ADHD, and contribute to precision medicine.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
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• 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

Locations
Other Locations
Taiwan
National Taiwan Univeristy Hospital
RECRUITING
Taipei
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 360
Treatments
ASD group
120 ASD patients (aged 5-18 years)
ADHD group
120 ADHD patients (aged 5-18 years)
TDC group
120 age-, and sex-matched typically developing controls (TDC) will be recruited from the same geographic areas of the ASD/ADHD groups via referral by teachers or the invitation of participants without any psychiatric disorders
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov