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Gut check: could probiotics help kids with autism handle stress?

NCT ID NCT06269614

Knowledge-focused Sponsor: Nova Southeastern University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the gut microbiome (the bacteria in our intestines) is linked to stress in children with autism or those who have experienced trauma. Researchers will give 75 children, ages 4 to 7, a probiotic powder for 4 weeks and measure changes in their gut bacteria and stress hormone levels. The goal is to better understand the connection between the gut and brain, not to test a treatment.

What this could mean

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

Active substance
Probiotic (dietary supplement)
What this could lead to
If successful, this could help us understand whether changing gut bacteria might help children with autism or stress manage their reactions better.
What could go wrong
This is a small, early-stage study with no control group for the probiotic. Results may not apply to all children, and the probiotic may cause mild digestive upset.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

Ages

4 years to 95 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Children diagnosed with Autism * Children with neurotypical development * Children in foster care * Children in homeless shelters * Children 4-7 years old * Must be able to watch a short video * Must be able to consume children's powder probiotics for 4 weeks Exclusion Criteria: * Children younger than 4, and older than 7.9 years old. * Inability to watch a screen * severe cognitive impairment

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder Fractures, Stress

As listed by the trial registrant

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

Adverse childhood experiences Autism spectrum disorder Stress reaction

Contacts and locations

Locations

  • Nova Southeastern University College of Nursing

    Davie, Florida, 33314, United States

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