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.
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.
Study Type
OBSERVATIONAL
Enrollment
23
The Center for Discovery
Harris, New York, United States
Gut Microbiome Alpha Diversity
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.
Time frame: Baseline, 3, 6, 9, and 12-14 months
Gut Microbiome Relative Abundance
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.
Time frame: Baseline, 3, 6, 9, and 12-14 months
Fecal Metabolomic Profile
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.
Time frame: Baseline, 3, 6, 9, and 12-14 months
Blood Metabolomic Profile and Steroid Levels
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).
Time frame: Baseline, 3, 6, 9, and 12-14 months
Urinary Metabolomic Profile
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.
Time frame: Baseline, 3, 6, 9, and 12-14 months
Gastrointestinal Severity (GI Severity Index)
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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.
Time frame: Baseline, 3, 6, 9, and 12-14 months
Functional Gastrointestinal Disorders Assessed by Rome IV
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.
Time frame: Baseline, 3, 6, 9, and 12-14 months
Gastrointestinal Signs and Symptoms Assessed by the GISSI-17
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).
Time frame: Baseline, 3, 6, 9, and 12-14 months
Behavioral Severity Assessed by the Aberrant Behavior Checklist (ABC)
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).
Time frame: Baseline, 3, 6, 9, and 12-14 months
Sensory Processing Assessed by the Child Sensory Profile 2
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).
Time frame: Baseline, 3, 6, 9, and 12-14 months
Repetitive Behaviors Assessed by the Repetitive Behavior Scale-Revised (RBS-R)
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).
Time frame: Baseline, 3, 6, 9, and 12-14 months