A Multi-dimensional Prospective Study to Discover Gene-microenvironment Interactions in Neurodevelopmental Disorders

NCT04878575 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2023-10-17

No results posted yet for this study

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.

Conditions

Interventions

OTHER

ASD diagnosis

Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)

OTHER

Psychiatric diagnosis

Kiddie Schedule for Affective Disorders \& Schizophrenia (K-SADS) for DSM-5

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878575 on ClinicalTrials.gov