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

9. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

600

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
ISAA Total Score
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Saveetha University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

31. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juni 2026

Zuerst gepostet (Tatsächlich)

15. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 079/06/2026/ISRB/FSR/SIBMS

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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