Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder

Sponsor
Saveetha University
Study ID
NCT07646808
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 12 Years
Healthy Volunteers
Not accepted

Study Details

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that affects communication, behavior, sensory processing, and daily functioning. Recent research suggests that the gut microbiome, the community of microorganisms living in the gastrointestinal tract, may influence brain development and function through the gut-brain and gut-motor axes. Alterations in gut microbiome characteristics have been reported in children with ASD and may be associated with differences in neurodevelopmental outcomes. This observational study aims to investigate the association between gut microbiome characteristics and neurodevelopmental functioning in children with ASD. The study will evaluate multiple domains of functioning, including motor performance, sensory processing, behavior, cognition, sleep, and participation in daily activities. Gut microbiome characteristics will be assessed using stool sample analysis, and neurodevelopmental outcomes will be measured using standardized assessments and validated questionnaires. The findings of this study may improve understanding of the relationship between the gut microbiome and neurodevelopmental functioning in children with ASD and provide insights into the role of the gut-motor axis in shaping functional outcomes. This knowledge may support future research and contribute to the development of more personalized approaches to assessment and rehabilitation in ASD.

Key Dates

First listed
Jun 15, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Children With Autism Spectrum Disorder
    Children diagnosed with Autism Spectrum Disorder (ASD) who meet the study eligibility criteria. Participants will provide stool samples for gut microbiome analysis and undergo multidomain neurodevelopmental assessment.
  • Arm: Typically Developing Children
    Age- and sex-matched typically developing children without a diagnosis of Autism Spectrum Disorder or other neurodevelopmental disorders. Participants will provide stool samples for gut microbiome analysis and undergo neurodevelopmental assessment for comparison with the ASD cohort.

Primary Outcome Measure

Indian Scale for Assessment of Autism [ Time Frame: Baseline ]

Central Contacts

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