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.
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
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
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.
Cohort
Prospective
Not listed
Indian Scale for Assessment of Autism
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
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.
Gross Motor Function Measure-88 Total Score
Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88). The GMFM-88 evaluates gross motor performance across five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. Scores range from 0 to 100%, with higher scores indicating better gross motor function (better outcomes) and lower scores indicating poorer gross motor function (worse outcomes). Total scores and dimension scores will be used to evaluate motor performance and its association with gut microbiome characteristics.
Gastrointestinal Symptom Severity Score
Gastrointestinal symptoms, including constipation, diarrhea, abdominal pain, and bloating, will be assessed using a structured Gastrointestinal Symptom Questionnaire (total score range: 0-100, with higher scores indicating greater gastrointestinal symptom severity). Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), a 7-point scale ranging from Type 1 (separate hard lumps, indicating severe constipation) to Type 7 (entirely liquid stool, indicating severe diarrhea), with higher scores reflecting looser stool consistency.
Strengths and Difficulties Questionnaire Total Difficulties Score
Emotional and behavioral difficulties will be assessed using the Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Score. The total difficulties score ranges from 0 to 40, with higher scores indicating greater emotional and behavioral difficulties (worse outcomes) and lower scores indicating fewer difficulties (better outcomes).
Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale Score
Sleep disturbance will be assessed using the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale (PROMIS Sleep Disturbance Scale). The scale evaluates perceived sleep quality, sleep difficulties, sleep satisfaction, and sleep-related concerns. Scores range from 8 to 40, with higher scores indicating greater sleep disturbance (worse sleep outcomes) and lower scores indicating better sleep quality. Associations between sleep disturbance and gut microbiome characteristics will be examined.
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