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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

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

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Индия · 1 центр

• Saveetha Medical College and Hospital — Chennai

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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