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

12 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

600

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Inde
    • Tamil Nadu
      • Chennai, Tamil Nadu, Inde, 602 105
        • Saveetha Medical College and Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Gut Microbiome Diversity and Composition
Délai: 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)
Indian Scale for Assessment of Autism
Délai: 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.
Baseline

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Gross Motor Function Measure-88 Total Score
Délai: Baseline
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.
Baseline
Gastrointestinal Symptom Severity Score
Délai: Baseline
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.
Baseline
Strengths and Difficulties Questionnaire Total Difficulties Score
Délai: Baseline
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).
Baseline
Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale Score
Délai: Baseline
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.
Baseline
Participation Questionnaire for Preschoolers With Autism Score
Délai: 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. The total score ranges from 0 to 100, with higher scores indicating greater participation in everyday activities (better outcomes) and lower scores indicating reduced participation. Associations between participation outcomes and gut microbiome characteristics will be examined.
Baseline
Sensory Experiences Questionnaire Total Score
Délai: Baseline
Sensory processing will be assessed using the Sensory Experiences Questionnaire Version 2.1 (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. The total score ranges from 0 to 145, with higher scores indicating greater sensory processing difficulties (worse outcomes) and lower scores indicating fewer sensory processing difficulties. Associations between sensory processing outcomes and gut microbiome characteristics will be examined.
Baseline
PROMIS Parent Proxy Cognitive Function Score
Délai: Baseline
Cognitive functioning will be assessed using the Patient-Reported Outcomes Measurement Information System Parent Proxy Cognitive Function Measure (PROMIS Parent Proxy Cognitive Function Measure). The instrument evaluates caregiver-reported difficulties related to attention, memory, concentration, learning, and thinking abilities in children. Scores are reported as standardized T-scores (mean = 50, standard deviation = 10), with higher scores indicating better perceived cognitive functioning (better outcomes) and lower scores indicating poorer cognitive functioning (worse outcomes). Associations between cognitive function and gut microbiome characteristics will be examined.
Baseline
Dietary Intake Score
Délai: 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 (kcal/day), macronutrient intake (g/day), dietary fiber intake (g/day), and consumption of key food groups (servings/day) will be recorded. A supplementary Food Frequency Questionnaire (FFQ) will assess the habitual consumption of fruits and vegetables, whole grains, fermented foods, sugar-sweetened beverages, and ultra-processed foods. Composite Healthy Diet Score and Unhealthy Diet Score will be derived to characterize dietary patterns, with higher Healthy Diet Scores indicating healthier dietary patterns and higher Unhealthy Diet Scores indicating less healthy dietary patterns. Dietary intake variables will be used as covariates in analyses examining associations between gut microbiome characteristics and neurodevelopmental functioning in children with
Baseline
Pediatric Quality of Life Inventory Total Score
Délai: 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. Scores range from 0 to 100, with higher scores indicating better health-related quality of life (better outcomes) and lower scores indicating poorer health-related quality of life (worse outcomes). Associations between quality of life and gut microbiome characteristics will be examined in children with Autism Spectrum Disorder.
Baseline
Anthropometric Nutritional Status Score
Délai: Baseline
Anthropometric nutritional status will be assessed using standardized measurements of height (cm), weight (kg), and body mass index (BMI; kg/m²). 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 the World Health Organization (WHO) Child Growth Standards and Growth Reference charts. For z-score indicators, a value of 0 represents the WHO reference population median, positive values indicate measurements above the reference median, and negative values indicate measurements below the reference median. Nutritional status categories, including undernutrition, normal nutritional status, overweight, and obesity, will be determined using WHO classification criteria. Associations between anthropometric nutritional status and gut microbiome characteristics will be examined in children with Autism Spectrum Disorder.
Baseline
Body Mass Index-for-Age Z-Score
Délai: 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 World Health Organization (WHO) age- and sex-specific growth references. A z-score of 0 represents the WHO reference population median, positive z-scores indicate BMI values above the reference median, and negative z-scores indicate BMI values below the reference median. BMI-for-age z-scores will be used to evaluate nutritional status and examine their association with gut microbiome characteristics and neurodevelopmental functioning.
Baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Saveetha University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

31 décembre 2026

Dates d'inscription aux études

Première soumission

9 juin 2026

Première soumission répondant aux critères de contrôle qualité

9 juin 2026

Première publication (Réel)

15 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 079/06/2026/ISRB/FSR/SIBMS

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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