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Completed

NCT Number: NCT07744217

Identifying Biomarkers of Gastro Intestinal Comorbidities in Autism Spectrum Disorder

This study investigates the microbiome-gut-brain axis in pediatric autism spectrum disorder (ASD). By longitudinally tracking participants, the study evaluates whether multi-omic profiles (gut microbiota and metabolome) correlate with behavioral and gastrointestinal fluctuations over time.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Gastro Intestinal Diseases Mental Disorders Neurodevelopmental Disorders

Age range

5 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Center for Discovery

Harris, New York, 12742, United States

About this study

Participants undergo longitudinal tracking over a 12-14 month period. Biological specimens (stool, blood, and urine) and clinical/behavioral metadata are collected at three-month intervals and during acute exacerbations of GI or behavioral symptoms to characterize multi-omic alterations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 5-19 years old, male or female.
  • Confirmed ASD diagnosis using ADOS/ADOS-2 (or ADI-R).

Exclusion criteria

  • Past bowel surgery.
  • Serious chronic medical conditions (e.g., diabetes).
  • Use of anti-inflammatory medications.
  • History of inflammatory bowel disease, Celiac disease, H. pylori infection, or eosinophilic disorders.
  • Recent antibiotic use within 1 month prior to enrollment.

Treatment and study plan

Primary outcomes

  1. Gut Microbiome Alpha Diversity

    Time frame: Baseline, 3, 6, 9, and 12-14 months

    Evaluated via 16S rRNA and ITS gene sequencing from stool specimens to determine microbial diversity within a single sample.

    Unit of Measure: Shannon Diversity Index.

  2. Gut Microbiome Relative Abundance

    Time frame: Baseline, 3, 6, 9, and 12-14 months

    Evaluated via 16S rRNA and ITS gene sequencing from stool specimens to identify changes in specific microbial taxa.

    Unit of Measure: Relative abundance, reported as the percentage (%) of total bacterial sequences.

  3. Fecal Metabolomic Profile

    Time frame: Baseline, 3, 6, 9, and 12-14 months

    Characterization of stool specimens using mass spectrometry (LC-MS and GC-MS) to identify biochemical changes and microbial-produced metabolites.

    Unit of Measure: Relative concentration (or peak area abundance) of identified metabolites per gram of stool.

  4. Blood Metabolomic Profile and Steroid Levels

    Time frame: Baseline, 3, 6, 9, and 12-14 months

    Characterization of blood specimens using mass spectrometry to evaluate metabolomics, specifically focusing on steroid levels.

    Unit of Measure: Relative concentration of identified metabolites and steroids in blood volume (e.g., ng/mL).

  5. Urinary Metabolomic Profile

    Time frame: Baseline, 3, 6, 9, and 12-14 months

    Characterization of urine specimens using mass spectrometry to identify biochemical changes and microbial-produced metabolites.

    Unit of Measure: Relative concentration of identified metabolites in urine volume, normalized to creatinine.

Secondary outcomes

  1. Gastrointestinal Severity (GI Severity Index)

    Time frame: Baseline, 3, 6, 9, and 12-14 months

    Gastrointestinal symptoms evaluated using the GI Severity Index.

    Unit of Measure: Total score. Scores range from 0 to 14. Higher scores indicate more severe gastrointestinal symptoms.

  2. Functional Gastrointestinal Disorders Assessed by Rome IV

    Time frame: Baseline, 3, 6, 9, and 12-14 months

    Presence of functional gastrointestinal disorders evaluated using the Rome IV Diagnostic questionnaire.

    Unit of Measure: Number of participants (count) meeting the diagnostic criteria for one or more functional gastrointestinal disorders.

  3. Gastrointestinal Signs and Symptoms Assessed by the GISSI-17

    Time frame: Baseline, 3, 6, 9, and 12-14 months

    Gastrointestinal signs and symptoms evaluated using the 17-item GI Signs and Symptoms Inventory (GISSI).

    Unit of Measure: Total Score ranging from 0 to 17, alongside three primary algorithm-based risk categories: Functional Constipation (0-6 items), Functional Diarrhea (0-6 items), and Gastroesophageal Reflux Disease (GERD) (0-4 items).

  4. Behavioral Severity Assessed by the Aberrant Behavior Checklist (ABC)

    Time frame: Baseline, 3, 6, 9, and 12-14 months

    Behavioral characteristics evaluated using the ABC.

    Unit of Measure: Total score per domain. The five subscale score ranges for this outcome measure are Irritability (0-45), Lethargy/Social Withdrawal (0-48), Stereotypic Behavior (0-21), Hyperactivity/Noncompliance (0-48), and Inappropriate Speech (0-12).

  5. Sensory Processing Assessed by the Child Sensory Profile 2

    Time frame: Baseline, 3, 6, 9, and 12-14 months

    Sensory processing patterns evaluated using the Child Sensory Profile 2 assessment.

    Unit of Measure: Total score. The Behavioral Sections evaluate the child's behavioral footprint across Conduct Responses (scores 0-45), Social-Emotional Responses (scores 0-55), and Attentional Responses (scores 0-20).

  6. Repetitive Behaviors Assessed by the Repetitive Behavior Scale-Revised (RBS-R)

    Time frame: Baseline, 3, 6, 9, and 12-14 months

    Repetitive behaviors evaluated using the RBS-R.

    Unit of Measure: Total Score ranging from 0 to 129, alongside six subscale scores: Stereotyped Behavior (0-18), Self-Injurious Behavior (0-24), Compulsive Behavior (0-24), Ritualistic/Routine Behavior (0-18), Sameness Behavior (0-33), and Restricted Behavior (0-12).

Sponsors and collaborators

Lead sponsor

The Center for Discovery

Other

Collaborators

  • Baylor College of Medicine
  • Columbia University

Registry information

Official study title

Identifying Biomarkers of GI Comorbidities in ASD: A Longitudinal Pilot Study Linking Multi-Omics With Behavioral and Gastrointestinal Comorbidities

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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