A Pilot Study of Microbiome in Patients With Autism Spectrum Disorder and Their Unaffected Siblings

NCT ID: NCT05038748

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-12-31

Brief Summary

The primary aims are to identify important gut microbiota signatures for youth with ASD, to identify dysbiosis features for different levels of ASD features and clinical courses, to search the possibility to intervene the disease course if we can tease out the dysbiosis responsible for the flare-up and improvement of the symptoms of the disease. The secondary aims are to identify the clinical and neuropsychological measures that are associated with direct and indirect regulation or interactions from gut-brain axis signaling, and based our preliminary results on reducing the measures for future large-scale microbiome study in ASD.

Detailed Description

Background: Despite increased public awareness of autism spectrum d isorder (ASD) and extensive research on this neurodevelopmental disorder in the past decades, the underlying mechanisms of ASD remain unclear, and ASD is still recognized as having the highest disease and care burden among child psychiatric disorders regarding its long-term impairment across the lifespan. Hence, identifying the biomarkers for early detection and effective biological treatments for ASD is among the most challenging tasks all over the world. The concerns about physical comorbidities such as immune dysregulation, allergy, and gastrointestinal issues, etc. emerged in the recent decade. Hence, the new perspective of searching for the underlying mechanism for ASD also targets the associations between microbiota and ASD. However, despite many microbiome studies in ASD, they provided limited knowledge about the specific link that particular imbalance gut bacteria could affect the behavioral deficits in ASD because lack of consideration of the clinical and genetic heterogeneity of ASD. With only a few studies examining the well-defined ASD-related impairments, the GI system dysfunction, and the microbiomes, the associations among ASD-related symptoms, GI symptoms, and microbiota remain indistinct. Therefore, the investigators propose this pilot study to fill the gap between the potential role of microbiome as a biomarker for ASD to facilitate developing the treatment for ASD.

Method and material: The case-sibling control study design will be used to investigate microbiome in 60 probands with ASD, aged 7-25 yrs old, and 30 unaffected siblings either from the PI Gau's ASD cohort or the Department of Psychiatry, National Taiwan University Hospital. The parents of all the subjects will receive the Autism Diagnostic Interview-Revised (ADI-R) interviews and report on the questionnaires regarding autistic symptoms, emotional/behavioral problems, social functions, G-I symptoms, and life quality. The ASD and sibling subjects will receive the Autism Diagnostic Observation Scale and neuropsychological tasks. The experiment of microbiome will be conducted by the core lab of microbiome (co-PI Ni) at the college of medicine, National Taiwan University. The data analyses will combine microbiomics and the extensive behaviors/cognitive function variables to establish an objective potential pipeline.

Anticipated outcome: With the accomplishment of this project, the investigators will establish the comprehensive yet fewer bios for the ASD risk bio-factors in Asia, and provide the potential clinical interview and assessments related to GI symptoms regulated by microbiota. The potential biomarkers may be further used to developing the treatment for ASD.

Significance: Several features of this project constitute its significance: a wealth of measures of ASD phenotypes (valid phenotype), ASD as a catastrophic disease (importance), the first ASD study with unaffected sibling design for microbiomics studies in ASD (originality), and new approaches and technologies (novelty) for searching microbiomics in ASD.

Conditions

Autism Spectrum Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

ASD group

80 youths with the clinical diagnosis of ASD according to the DSM-5 diagnostic criteria

Psychiatric diagnosis

Intervention Type: OTHER

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

ASD diagnosis

Intervention Type: OTHER

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

Sibling group

30 unaffected siblings of ASD youths

Psychiatric diagnosis

Intervention Type: OTHER

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

TD group

40 healthy typical developing(TD) control from cohort established at Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007

Psychiatric diagnosis

Intervention Type: OTHER

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

Interventions

Psychiatric diagnosis

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

Intervention Type: OTHER

ASD diagnosis

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• a clinical diagnosis of ASD defined by the DSM-IV confirmed by ADI-R or ADOS and also clinical reappraisal based on the newly release DSM-5 criteria for ASD
• ages range from 7 to 25 at the time now
• at least one biological parent
• parents that are both Han Chinese in Taiwan

Exclusion Criteria

• intellectual disability
• epilepsy
• ADHD
• autoimmune diseases

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan Univeristy Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201810048RIND

Identifier Type: -

Identifier Source: org_study_id