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

NCT07646808 · tracked via the Priya Life Science India tracker

Sponsor

Saveetha University

Phase

Observational

Started

2026-07-01

Last updated

2026-06-16

Condition(s) studied

Autism Spectrum Disorder

Study summary

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.

Eligibility

Sex

ALL

Min age

3 Years

Max age

12 Years

Healthy volunteers

Inclusion Criteria: * Children aged 3 to 12 years * Clinical diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5/ICD criteria and confirmed from medical records or specialist assessment * Stable clinical status at the time of enrollment * Parent/legal guardian willing to provide written informed consent * Child able to undergo stool sample collection and neurodevelopmental assessments * Parent/caregiver able to complete questionnaires and provide dietary and medical history Exclusion Criteria: * Use of systemic antibiotics, probiotics, prebiotics, synbiotics, or bowel-cleansing agents within the previous 4-12 weeks before stool collection * Presence of acute gastrointestinal infection or acute febrile illness at the time of assessment * Known chronic gastrointestinal disorders that may independently alter the gut microbiome, such as inflammatory bowel disease, celiac disease, short bowel syndrome, or chronic intestinal malabsorption * Major neurological, genetic, or metabolic disorders other than ASD that may independently affect neurodevelopment * Current use of medications known to significantly affect gut microbiota or bowel motility, if clinically relevant to your protocol * Inability to provide stool sample or complete the required assessments * Refusal of consent by parent/legal guardian

Primary outcome measure(s)

Indian Scale for Assessment of Autism — Baseline
Autism severity will be assessed using the Indian Scale for Assessment of Autism (ISAA). The ISAA total score ranges from 40 to 200, with higher scores indicating greater autism symptom severity (worse outcomes) and lower scores indicating less severe autism-related impairments (better outcomes). The total score will be used to determine the severity of autism symptoms and examine associations with gut microbiome characteristics.
Gut Microbiome Diversity and Composition — Baseline (single stool sample collected at study enrollment)
Gut microbiome characteristics will be assessed from stool samples using 16S rRNA gene sequencing. Primary microbiome outcomes will include alpha diversity indices (Shannon Diversity Index, Simpson Diversity Index, and Chao1 Richness Index), beta diversity measures, and the relative abundance of bacterial taxa. These measures will be used to characterize gut microbial diversity and composition in children with Autism Spectrum Disorder.

Trial sites (1)

Facility	City	Region	Status
Saveetha Medical College and Hospital	Chennai	Tamil Nadu

Other trials for the same condition

Efficacy of Low Glycemic Index Diet vs Modified Atkins Diet and Gluten Free Casein Free Diet as add-on Therapy With Standard of Care in Children With Autism Spectrum Disorder Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07646808 on ClinicalTrials.gov ↗ ← All trials in India