- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04878575
A Multi-dimensional Prospective Study to Discover Gene-microenvironment 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
Study Overview
Status
Intervention / Treatment
Detailed Description
Autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD) are common neurodevelopmental disorders in Taiwan and worldwide (prevalence rate, ASD, 1%; ADHD, 3-10%), presenting as clinically and genetically heterogeneous disorders with early onset at childhood lasting to adulthood. Both disorders bring a tremendous impact on individuals, families, and society. Despite extensive studies on these two disorders, our knowledge about their pathogenetic mechanism is still minimal, and there are no biomarkers for effective prevention, early detection, diagnosis and biological treatment (ineffective in 30% ADHD patients, none for ASD). Although they have distinct symptom inclusion criteria and intervention, emerging evidence suggests that ASD and ADHD may share some genetic influences and susceptibility involving neuroanatomical phenotypes, cognitive deficits, and behavioral phenotypes. However, few studies have investigated these two disorders simultaneously. Moreover, the role of metabolomics and microbiome in neuropsychiatric disorders has drawn much attention recently. With the PI's long-term commitment to the neurocognitive/imaging/gene research ADHD and ASD in separate projects, our knowledge about these two disorders improved, but their underlying pathogenesis remains unclear. Hence, a multi-dimensional prospective gut-brain axis integration study highlighting the metabolism in the whole body to identify the common and unique factors of these two disorders and discover their gene-microenvironment interaction mechanism is extremely urgent and warranted.
Specific Aims:
- To identify and compare the early environmental factors (e.g., maternal, and pre-, peri-, and post-natal factors) affecting the gut- microbiome, cognition, and brain structures and functions among the ASD, ADHD and TDC groups at ages of 4-12 years old;
- To investigate the symptomatology, neuropsychology, neuroimaging, gut microbiome and metabolic biomarker signatures at Time 1 and Time 2 among the three groups while considering food, GI symptoms, and life style;
- To investigate the changes (Time2-Time1), stability, and interactions of the symptomatology, neuropsychology, neuroimaging (MRI+MRS), gut microbiome and metabolic biomarker signatures in youths with ASD and ADHD as compared to TDC over a 2-4-year follow-up period.
- To identify the predictors from the environmental (perinatal, food, lifestyle, family, school, neighborhood) and individual (behavior, gut microbiota, metabolomics, brain structure) factors for the neurocognitive/brain function and psychosocial outcomes in the follow-up.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan
- Recruiting
- National Taiwan Univeristy Hospital
-
Contact:
- Susan Shur-Fen Gau, MD, PhD
- Phone Number: 66802 886-2-23123456
- Email: gaushufe@ntu.edu.tw
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ASD group
120 ASD patients (aged 5-18 years)
|
Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)
Kiddie Schedule for Affective Disorders & Schizophrenia (K-SADS) for DSM-5
|
ADHD group
120 ADHD patients (aged 5-18 years)
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Kiddie Schedule for Affective Disorders & Schizophrenia (K-SADS) for DSM-5
|
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
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Kiddie Schedule for Affective Disorders & Schizophrenia (K-SADS) for DSM-5
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychological functions: Continuous Performance Test(CPT)
Time Frame: 15 minutes
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The 4 dimensions of CPT: focused attention, hyperactivity/impulsivity, sustained attention, and vigilance
|
15 minutes
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Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)
Time Frame: 1.5 hours
|
The 4 main cognitive components of CANTAB: Visual Memory, Attention, Working and Planning Memory (Executive Functions), and Decision Making
|
1.5 hours
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Structural neuroimaging: Diffusing spectrum imaging (DSI)
Time Frame: 1 hour
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DSI is performed using a pulsed-gradient spin-echo diffusion echo planar imaging (EPI) sequence with 102 diffusion-encoding directions
|
1 hour
|
Multi-echo resting-state fMRI (rfMRI)
Time Frame: 1 hour
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rfMRI will be used to evaluate resting-state connectivity
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1 hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201903105RINB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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