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

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

600

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ISAA Total Score
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gross Motor Function Measure-88 (GMFM-88) Total Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
Behavioral functioning will be assessed using the SDQ. Higher scores indicate greater behavioral and emotional difficulties.
Baseline
PROMIS Sleep Disturbance Scale Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

Saveetha University

Publikationer og nyttige links

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Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 079/06/2026/ISRB/FSR/SIBMS

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

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.

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