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

Official title

Association Between Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder: A Multidomain Investigation of the Gut-Motor Axis

Overview

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.

Detailed description

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterized by impairments in social communication, restricted and repetitive behaviors, sensory processing differences, and variable functional abilities across developmental domains. Increasing evidence suggests that the gut microbiome may play a role in neurodevelopment through bidirectional communication pathways linking the gastrointestinal system and the central nervous system. These interactions, commonly described as the gut-brain axis, have been implicated in behavioral, cognitive, sensory, and motor processes. More recently, the concept of the gut-motor axis has emerged, highlighting potential relationships between gut microbial composition and motor functioning.

Several studies have reported alterations in gut microbiome composition among children with ASD compared with typically developing peers. However, existing research has largely focused on autism symptom severity, behavioral manifestations, or gastrointestinal symptoms, while the association between gut microbiome characteristics and broader neurodevelopmental functioning remains insufficiently explored. Furthermore, few studies have examined multiple functional domains simultaneously within a rehabilitation framework.

The present study aims to investigate the association between gut microbiome characteristics and neurodevelopmental functioning in children with ASD. A multidomain assessment approach will be employed to evaluate neurodevelopmental outcomes encompassing motor performance, sensory processing, behavioral function, cognitive functioning, sleep, and participation in daily activities. Gut microbiome characteristics will be assessed through stool sample analysis using established microbiological methods. Neurodevelopmental outcomes will be evaluated using standardized assessments and validated caregiver-reported instruments.

By examining the relationship between gut microbiome characteristics and multidimensional functional outcomes, this study seeks to enhance understanding of the gut-motor axis in ASD and identify potential microbiome-related factors associated with neurodevelopmental functioning. The findings may contribute to the growing body of evidence on microbiome-neurodevelopment interactions and inform future translational and rehabilitation research in children with ASD.

Primary outcome measures

• Indian Scale for Assessment of Autism [Time frame: Baseline]
• Gut Microbiome Diversity and Composition [Time frame: Baseline (single stool sample collected at study enrollment)]

Secondary outcome measures (11)

• Gross Motor Function Measure-88 Total Score [Time frame: Baseline]
• Gastrointestinal Symptom Severity Score [Time frame: Baseline]
• Strengths and Difficulties Questionnaire Total Difficulties Score [Time frame: Baseline]
• Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale Score [Time frame: Baseline]
• Participation Questionnaire for Preschoolers With Autism Score [Time frame: Baseline]
• Sensory Experiences Questionnaire Total Score [Time frame: Baseline]
• PROMIS Parent Proxy Cognitive Function Score [Time frame: Baseline]
• Dietary Intake Score [Time frame: Baseline]
• Pediatric Quality of Life Inventory Total Score [Time frame: Baseline]
• Anthropometric Nutritional Status Score [Time frame: Baseline]
• Body Mass Index-for-Age Z-Score [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

India · 1 center

• Saveetha Medical College and Hospital — Chennai

Publications

• 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
• 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
• 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
• 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 PMID 31460832

Identifiers

NCT: NCT07646808 · 079/06/2026/ISRB/FSR/SIBMS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗