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

NCT05038748 | Completed DMC

• 1 other identifier: 201810048RIND
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Autism Diagnostic Interview-Revised (ADI-R)

  Including reciprocal social interaction, communication, and repetitive behaviors and stereotyped patterns, for children with a mental age from about 18 months into adulthood. The coding of some items is converted to numeric scores "0" if no evidence of abnormality exists, "1" if some evidence of abnormality exists, and "2" if evidence of marked abnormality. Higher scores mean more severe clinical deficits.

  1 hour

• Autism Diagnostic Observation Scale (ADOS)

  Including communication, social interaction, creativity, stereotyped behaviors and restricted interests. The coding of some items is converted to numeric scores "0" if no evidence of abnormality exists, "1" if some evidence of abnormality exists, and "2" if evidence of marked abnormality. Higher scores mean more severe clinical deficits.

  1 hour

Study Arms (3)

ASD group

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

Other: Psychiatric diagnosis; Other: ASD diagnosis

Sibling group

30 unaffected siblings of ASD youths

Other: Psychiatric diagnosis

TD group

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

Other: Psychiatric diagnosis

Interventions

Psychiatric diagnosis OTHER

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

ASD group; Sibling group; TD group

ASD diagnosis OTHER

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

ASD group

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The cohort was established at the Department of Psychiatry, National Taiwan University Hospital (NTUH) starting from 2007.

You may qualify if:

• 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

You may not qualify if:

• intellectual disability
• epilepsy
• ADHD
• autoimmune diseases

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

5 g of stool sample

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 9, 2021
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-01

Locations

TW (1)