Gut bacteria and development in children with autism spectrum disorder
Looks at links between gut bacteria and development in children with autism.
Plain-language title generated from the registry record
Registry title: Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder
Key facts
- Where
- Chennai, IndiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 12 years old?
Source: NCT07646808, who can take part
Where in India
- Saveetha Medical College and HospitalChennai, IndiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Saveetha University
- Trial code
- NCT07646808
- Record updated
- 16 June 2026
- Original description
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.Read full original descriptionShow less
Association Between Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder: A Multidomain Investigation of the Gut-Motor Axis
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.
Inclusion: 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: 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; 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; Inability to provide stool sample or complete the required assessments; Refusal of consent by parent/legal guardian.