NCT07646808Not yet recruiting
Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder
Association Between Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder: A Multidomain Investigation of the Gut-Motor Axis
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Saveetha University
- Diseases
- Autism
- NCT number
- NCT07646808
What you commit to
- Study type: Observational
- Planned participants: 600
- From 1 Jul 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of systemic antibiotics, probiotics, prebiotics, synbiotics, or bowel-cleansing agents within the previous 4-12 weeks before stool collection
- Current use of medications known to significantly affect gut microbiota or bowel motility, if clinically relevant to your protocol
Other illness
- 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
Other
- Inability to provide stool sample or complete the required assessments
- Refusal of consent by parent/legal guardian
Who the study is looking for
- 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
Age in the registry: 3 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saveetha Medical College and Hospital Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.