AutismNCT07744217
Identifying Biomarkers of Gastro Intestinal Comorbidities in Autism Spectrum Disorder
An observational study of Autism and Gastro Intestinal Diseases, run by The Center for Discovery at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 19 years
- Conditions the study is for
- Autism, Gastro Intestinal Diseases
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 6 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consists of male and female pediatric and adolescent patients, aged 5 to 19 years old, who were consecutively admitted to a residential facility (The Center for Discovery). These individuals have a confirmed diagnosis of Autism Spectrum Disorder (ASD), verified via the Autism Diagnostic Observation Schedule (ADOS or ADOS-2) or a widely accepted alternative such as the Autism Diagnostic Interview-R (ADI-R). This residential population is characterized by complex ASD often accompanied by multiple medical comorbidities, allowing for a strictly controlled environment and reliable longitudinal follow-up
Who may be able to join
- Age 5-19 years old, male or female.
- Confirmed ASD diagnosis using ADOS/ADOS-2 (or ADI-R).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Biomarkers of GI Comorbidities in ASD: A Longitudinal Pilot Study Linking Multi-Omics With Behavioral and Gastrointestinal Comorbidities
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.
Read the 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.
- Conditions
- Autism, Gastro Intestinal Diseases
- Keywords
- Microbiome, Metabolomics, Biomarkers, Pediatric ASD
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric ASD Cohort | A single cohort of 23 pediatric patients, aged 5-19 years, admitted to The Center for Discovery with a confirmed Autism Spectrum Disorder diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, 3, 6, 9, and 12-14 months
Secondary outcomes (6)
Gastrointestinal Severity (GI Severity Index)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 3, 6, 9, and 12-14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start3 Feb 2021
- Primary completion9 Feb 2025
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Discovery
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Baylor College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744217
- Sponsor's protocol ID
- 5150-057
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified multi-omic data, including 16S rRNA and ITS gene sequencing and metabolomic profiles, alongside associated de-identified assessment results and clinical metadata, will be shared to support reproducibility and generalized knowledge.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biomarkers of GI Comorbidities in ASD: A Longitudinal Pilot Study Linking Multi-Omics With Behavioral and Gastrointestinal Comorbidities
- ClinicalTrials.gov ID
- NCT07744217
- Acronym / sponsor ID
- 5150-057
- Conditions
- Autism, Gastro Intestinal Diseases
- Keywords
- Microbiome, Metabolomics, Biomarkers, Pediatric ASD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The Center for DiscoveryUniversity, hospital or other
- Collaborators
- Columbia University, Baylor College of Medicine
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 9 Feb 2025 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric ASD Cohort | – | –A single cohort of 23 pediatric patients, aged 5-19 years, admitted to The Center for Discovery with a confirmed Autism Spectrum Disorder diagnosis. |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of male and female pediatric and adolescent patients, aged 5 to 19 years old, who were consecutively admitted to a residential facility (The Center for Discovery). These individuals have a confirmed diagnosis of Autism Spectrum Disorder (ASD), verified via the Autism Diagnostic Observation Schedule (ADOS or ADOS-2) or a widely accepted alternative such as the Autism Diagnostic Interview-R (ADI-R). This residential population is characterized by complex ASD often accompanied by multiple medical comorbidities, allowing for a strictly controlled environment and reliable longitudinal follow-up
Key inclusion criteria (2 listed)
- Age 5-19 years old, male or female.
- Confirmed ASD diagnosis using ADOS/ADOS-2 (or ADI-R).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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).
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.
6 secondary outcomes
Gastrointestinal Severity (GI Severity Index)
Time frame: Baseline, 3, 6, 9, and 12-14 months
Functional Gastrointestinal Disorders Assessed by Rome IV
Time frame: Baseline, 3, 6, 9, and 12-14 months
Gastrointestinal Signs and Symptoms Assessed by the GISSI-17
Time frame: Baseline, 3, 6, 9, and 12-14 months
Behavioral Severity Assessed by the Aberrant Behavior Checklist (ABC)
Time frame: Baseline, 3, 6, 9, and 12-14 months
Sensory Processing Assessed by the Child Sensory Profile 2
Time frame: Baseline, 3, 6, 9, and 12-14 months
Repetitive Behaviors Assessed by the Repetitive Behavior Scale-Revised (RBS-R)
Time frame: Baseline, 3, 6, 9, and 12-14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified multi-omic data, including 16S rRNA and ITS gene sequencing and metabolomic profiles, alongside associated de-identified assessment results and clinical metadata, will be shared to support reproducibility and generalized knowledge.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Gastro Intestinal Diseases, run by The Center for Discovery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome Alpha Diversity (time frame: Baseline, 3, 6, 9, and 12-14 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.