[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641728":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":22,"responsibleParty":41,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Saveetha University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Children With Autism Spectrum Disorder",null,"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.",{"label":13,"type":10,"description":14,"interventionNames":10},"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.",[16],{"name":17,"role":18,"phone":19,"phoneExt":20,"email":21},"Jeevarathinam Thirumalai, MPT","CONTACT","6384577805","+91","jeevarathinamhope@gmail.com",[23],{"facility":24,"status":10,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Saveetha Medical College and Hospital","Chennai","Tamil Nadu","602 105","India","IN",{"type":31,"coordinates":32},"Point",[33,34],80.27847,13.08784,{"lat":34,"lon":33},[37],{"name":38,"role":18,"phone":39,"phoneExt":20,"email":40},"Indra Sivakumar, PhD","9444009042","indras.smc@saveetha.com",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Jeevarathinam Thirumalai","Principal Investigator","100641728","gut-microbiome-characteristics-and-neurodevelopmental-functioning-in-children-with-autism-spectrum-disorder-100641728",false,"NCT07646808","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","GAIN-ASD","Inclusion Criteria:\n\n* Children aged 3 to 12 years\n* Clinical diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5\u002FICD criteria and confirmed from medical records or specialist assessment\n* Stable clinical status at the time of enrollment\n* Parent\u002Flegal guardian willing to provide written informed consent\n* Child able to undergo stool sample collection and neurodevelopmental assessments\n* Parent\u002Fcaregiver able to complete questionnaires and provide dietary and medical history\n\nExclusion Criteria:\n\n* Use of systemic antibiotics, probiotics, prebiotics, synbiotics, or bowel-cleansing agents within the previous 4-12 weeks before stool collection\n* Presence of acute gastrointestinal infection or acute febrile illness at the time of assessment\n* 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\n* Major neurological, genetic, or metabolic disorders other than ASD that may independently affect neurodevelopment\n* Current use of medications known to significantly affect gut microbiota or bowel motility, if clinically relevant to your protocol\n* Inability to provide stool sample or complete the required assessments\n* Refusal of consent by parent\u002Flegal guardian","ALL","3 Years","12 Years",{"count":57,"type":58},600,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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.\n\nThe 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.",[62],"Autism Spectrum Disorder",[62,64,65,66,67],"Gut Microbiome","Gut-Brain Axis","Gut-Motor Axis","Motor Performance","NOT_YET_RECRUITING","2026-06-12",{"date":71,"type":72},"2026-06-16","ACTUAL",{"date":74,"type":58},"2026-07-01",{"date":76,"type":58},"2026-12-31",{"name":5,"class":6},1]