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Could gut microbes hold clues to autism symptoms?

NCT ID NCT07744217

Knowledge-focused Sponsor: The Center for Discovery Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study looks at how the gut microbiome and its chemical byproducts relate to gastrointestinal and behavioral symptoms in children with autism. By tracking 23 participants over time, researchers hope to identify biological markers that could one day help manage these symptoms. The study is observational, meaning it does not test a treatment but gathers information.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to biomarkers that help predict or manage gastrointestinal issues in autism, potentially improving quality of life.
What could go wrong
This is a small pilot study, so findings may not be definitive or generalizable. It is observational and does not test a treatment, so it won't directly change care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

23 people

The number who actually took part.

Started

Feb 2021

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

5 to 19 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder digestive system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism Gastro intestinal diseases

Contacts and locations

Locations

  • The Center for Discovery

    Harris, New York, 12742, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.