Autism, Gastro Intestinal Diseases
Conditions
Keywords
Microbiome, Metabolomics, Biomarkers, Pediatric ASD
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
The Center for Discovery
Columbia University
Baylor College of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 19 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut Microbiome Alpha Diversity | 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. |
| Gut Microbiome Relative Abundance | 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. |
| Fecal Metabolomic Profile | 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. |
| Blood Metabolomic Profile and Steroid Levels | 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). |
| Urinary Metabolomic Profile | 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
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Severity (GI Severity Index) | 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. |
| Functional Gastrointestinal Disorders Assessed by Rome IV | 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. |
| Gastrointestinal Signs and Symptoms Assessed by the GISSI-17 | 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). |
| Behavioral Severity Assessed by the Aberrant Behavior Checklist (ABC) | 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). |
| Sensory Processing Assessed by the Child Sensory Profile 2 | 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). |
| Repetitive Behaviors Assessed by the Repetitive Behavior Scale-Revised (RBS-R) | 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). |
Countries
United States
Outcome results
None listed