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

NCT07646808 | Not Yet Recruiting DMC

• 1 other identifier: 079/06/2026/ISRB/FSR/SIBMS
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Gut Microbiome; Gut-Brain Axis; Gut-Motor Axis; Motor Performance

Outcome Measures

Primary Outcomes (2)

• ISAA Total Score

  Autism severity will be assessed using the Indian Scale for Assessment of Autism (ISAA). The total score will be used to determine the severity of autism symptoms and examine associations with gut microbiome characteristics.

  Baseline

• Gut Microbiome Diversity and Composition

  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.

  Baseline (single stool sample collected at study enrollment)

Secondary Outcomes (11)

• Gross Motor Function Measure-88 (GMFM-88) Total Score

  Baseline

• Gastrointestinal Symptom Severity Score

  Baseline

• Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Score

  Baseline

• PROMIS Sleep Disturbance Scale Score

  Baseline

• Participation Questionnaire for Preschoolers With Autism (PPA) Score

  Baseline

Study Arms (2)

Children With Autism Spectrum Disorder

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.

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.

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of children aged 3 to 12 years with a confirmed diagnosis of Autism Spectrum Disorder (ASD) who are receiving care at participating pediatric rehabilitation, developmental, neurology, psychiatry, and autism care centers. Eligible participants will undergo stool sample collection for gut microbiome analysis and multidomain neurodevelopmental assessment, including evaluation of autism severity, gross motor function, sensory processing, cognitive functioning, behavioral function, sleep, participation, quality of life, gastrointestinal symptoms, dietary intake, and anthropometric nutritional status. Written informed consent will be obtained from parents or legal guardians prior to participation.

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

Sponsors & Collaborators

• Saveetha University: lead

Study Sites (1)

Saveetha Medical College and Hospital

Chennai, Tamil Nadu, 602 105, India

Location

Related Publications (4)

• Baranek GT, Watson LR, Boyd BA, Poe MD, David FJ, McGuire L. Hyporesponsiveness to social and nonsocial sensory stimuli in children with autism, children with developmental delays, and typically developing children. Dev Psychopathol. 2013 May;25(2):307-20. doi: 10.1017/S0954579412001071.

  PMID: 23627946 BACKGROUND

• Kang DW, Adams JB, Gregory AC, Borody T, Chittick L, Fasano A, Khoruts A, Geis E, Maldonado J, McDonough-Means S, Pollard EL, Roux S, Sadowsky MJ, Lipson KS, Sullivan MB, Caporaso JG, Krajmalnik-Brown R. Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study. Microbiome. 2017 Jan 23;5(1):10. doi: 10.1186/s40168-016-0225-7.

  PMID: 28122648 BACKGROUND

• Vuong HE, Hsiao EY. Emerging Roles for the Gut Microbiome in Autism Spectrum Disorder. Biol Psychiatry. 2017 Mar 1;81(5):411-423. doi: 10.1016/j.biopsych.2016.08.024. Epub 2016 Aug 26.

  PMID: 27773355 BACKGROUND

• Cryan JF, O'Riordan KJ, Cowan CSM, Sandhu KV, Bastiaanssen TFS, Boehme M, Codagnone MG, Cussotto S, Fulling C, Golubeva AV, Guzzetta KE, Jaggar M, Long-Smith CM, Lyte JM, Martin JA, Molinero-Perez A, Moloney G, Morelli E, Morillas E, O'Connor R, Cruz-Pereira JS, Peterson VL, Rea K, Ritz NL, Sherwin E, Spichak S, Teichman EM, van de Wouw M, Ventura-Silva AP, Wallace-Fitzsimons SE, Hyland N, Clarke G, Dinan TG. The Microbiota-Gut-Brain Axis. Physiol Rev. 2019 Oct 1;99(4):1877-2013. doi: 10.1152/physrev.00018.2018.

  PMID: 31460832 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples will be collected from participants and retained for microbiome analysis. Microbial DNA will be extracted from stool specimens for characterization of gut microbiome composition and diversity using established molecular techniques. Biospecimens will be stored under appropriate laboratory conditions and used solely for research purposes related to the study objectives.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Jeevarathinam Thirumalai, MPT

CONTACT

6384577805; jeevarathinamhope@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

IN (1)