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

Starting soon

Conditions studied: Autism Spectrum Disorder

In brief

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 facts

Study ID: NCT07646808
Run by: Saveetha University
People needed: 600
Starts: 2026-07-01
Expected to finish: 2026-12-31
Last updated by the study team: 2026-06-16

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Saveetha Medical College and Hospital — Chennai, Tamil Nadu, India

Full record on ClinicalTrials.gov

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