Association Between Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder: A Multidomain Investigation of the Gut-Motor Axis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Indian Scale for Assessment of Autism
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Indian Scale for Assessment of Autism
时间窗: Baseline
Autism severity will be assessed using the Indian Scale for Assessment of Autism (ISAA). The ISAA total score ranges from 40 to 200, with higher scores indicating greater autism symptom severity (worse outcomes) and lower scores indicating less severe autism-related impairments (better outcomes). The total score will be used to determine the severity of autism symptoms and examine associations with gut microbiome characteristics.
Gut Microbiome Diversity and Composition
时间窗: Baseline (single stool sample collected at study enrollment)
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.
次要结局
- Gross Motor Function Measure-88 Total Score(Baseline)
- Gastrointestinal Symptom Severity Score(Baseline)
- Strengths and Difficulties Questionnaire Total Difficulties Score(Baseline)
- Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale Score(Baseline)
- Participation Questionnaire for Preschoolers With Autism Score(Baseline)
- Sensory Experiences Questionnaire Total Score(Baseline)
- PROMIS Parent Proxy Cognitive Function Score(Baseline)
- Dietary Intake Score(Baseline)
- Pediatric Quality of Life Inventory Total Score(Baseline)
- Anthropometric Nutritional Status Score(Baseline)
- Body Mass Index-for-Age Z-Score(Baseline)
研究者
Jeevarathinam Thirumalai
Principal Investigator
Saveetha University