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Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder (GAIN-ASD)

9. června 2026 aktualizováno: Jeevarathinam Thirumalai, Saveetha University

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

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

600

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Indie
    • Tamil Nadu
      • Chennai, Tamil Nadu, Indie, 602 105
        • Saveetha Medical College and Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
ISAA Total Score
Časové okno: Baseline
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
Časové okno: 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.
Baseline (single stool sample collected at study enrollment)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Gross Motor Function Measure-88 (GMFM-88) Total Score
Časové okno: Baseline
Gross motor function will be assessed using the GMFM-88. Total scores and dimension scores will be used to evaluate motor performance and its association with gut microbiome characteristics.
Baseline
Gastrointestinal Symptom Severity Score
Časové okno: Baseline
Gastrointestinal symptoms including constipation, diarrhea, abdominal pain, bloating, and stool consistency will be assessed using a structured gastrointestinal symptom questionnaire and Bristol Stool Form Scale.
Baseline
Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Score
Časové okno: Baseline
Behavioral functioning will be assessed using the SDQ. Higher scores indicate greater behavioral and emotional difficulties.
Baseline
PROMIS Sleep Disturbance Scale Score
Časové okno: Baseline
Sleep disturbance will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale. The scale evaluates perceived sleep quality, sleep difficulties, sleep satisfaction, and sleep-related concerns. Higher scores indicate greater sleep disturbance. Associations between sleep disturbance and gut microbiome characteristics will be examined.
Baseline
Participation Questionnaire for Preschoolers With Autism (PPA) Score
Časové okno: Baseline
Participation will be assessed using the Participation Questionnaire for Preschoolers With Autism (PPA). The questionnaire evaluates participation in home, preschool, community, play, and social activities. Higher scores indicate greater participation in everyday activities. Associations between participation outcomes and gut microbiome characteristics will be examined.
Baseline
Sensory Experiences Questionnaire (SEQ-2.1) Total Score
Časové okno: Baseline
Sensory processing will be assessed using the Sensory Experiences Questionnaire (SEQ-2.1), a caregiver-reported measure designed to evaluate sensory experiences in children with Autism Spectrum Disorder. The questionnaire assesses sensory hyperreactivity, hyporeactivity, and sensory seeking behaviors across multiple sensory modalities. Higher scores indicate greater sensory processing difficulties.
Baseline
PROMIS Parent Proxy Cognitive Function Score
Časové okno: Baseline
Cognitive functioning will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Cognitive Function measure. The instrument evaluates caregiver-reported difficulties related to attention, memory, concentration, learning, and thinking abilities in children. Higher scores indicate better perceived cognitive functioning. Associations between cognitive function and gut microbiome characteristics will be examined.
Baseline
Dietary Intake Score
Časové okno: Baseline
Dietary intake will be assessed using parent proxy-reported 24-hour dietary recalls collected on 2-3 non-consecutive days, including at least one weekend day, using the multiple-pass recall method. Information on daily energy intake, macronutrient intake, dietary fiber intake, and consumption of key food groups will be recorded. A supplementary food frequency questionnaire will assess the habitual consumption of fruits and vegetables, whole grains, fermented foods, sugar-sweetened beverages, and ultra-processed foods. Composite healthy diet and unhealthy diet scores will be derived to characterize dietary patterns. Dietary intake variables will be used as covariates in analyses examining associations between gut microbiome characteristics and neurodevelopmental functioning in children with Autism Spectrum Disorder.
Baseline
Pediatric Quality of Life Inventory (PedsQL) Total Score
Časové okno: Baseline
Quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL). The instrument evaluates physical, emotional, social, and school functioning in children. Higher scores indicate better health-related quality of life. Associations between quality of life and gut microbiome characteristics will be examined in children with Autism Spectrum Disorder.
Baseline
Anthropometric Nutritional Status Score
Časové okno: Baseline
Anthropometric nutritional status will be assessed using standardized measurements of height, weight, and body mass index (BMI). Age- and sex-specific z-scores for weight-for-age, height-for-age, BMI-for-age, and weight-for-height (where applicable) will be calculated according to World Health Organization (WHO) Child Growth Standards and Growth Reference charts. Nutritional status categories including undernutrition, normal nutritional status, overweight, and obesity will be determined. Associations between anthropometric nutritional status and gut microbiome characteristics will be examined in children with Autism Spectrum Disorder.
Baseline
Body Mass Index-for-Age (BMI-for-Age) Z-Score
Časové okno: Baseline
Body mass index (BMI) will be calculated as weight (kg) divided by height squared (m²). BMI-for-age z-scores will be derived using WHO age- and sex-specific growth references. Higher or lower BMI-for-age z-scores will be used to evaluate nutritional status and their association with gut microbiome characteristics and neurodevelopmental functioning.
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Saveetha University

Publikace a užitečné odkazy

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Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

31. prosince 2026

Dokončení studie (Odhadovaný)

31. prosince 2026

Termíny zápisu do studia

První předloženo

9. června 2026

První předloženo, které splnilo kritéria kontroly kvality

9. června 2026

První zveřejněno (Aktuální)

15. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 079/06/2026/ISRB/FSR/SIBMS

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu IPD

Individual participant data (IPD) may be shared upon reasonable request following publication of the study findings, subject to institutional policies, ethical approval requirements, participant confidentiality protections, and applicable data-sharing agreements. A final decision regarding IPD sharing will be made after completion of the study and in accordance with institutional and regulatory guidelines.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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