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Can a gut microbe ease Autism's social struggles?

NCT ID NCT05307744

Symptom relief Sponsor: Chang Gung Memorial Hospital 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial tests whether a daily probiotic supplement called Lactobacillus plantarum PS128 can improve social and behavioral symptoms in children with autism spectrum disorder. School-aged children (7-12 years) will receive either the probiotic or a placebo for a period, and researchers will measure changes in social responsiveness and repetitive behaviors. The study explores the idea that balancing gut bacteria might influence brain function and behavior.

What this could mean

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

Active substance
Lactobacillus plantarum PS128, a probiotic supplement
What this could lead to
If effective, PS128 could offer a natural, gut-based approach to help ease social and behavioral challenges in children with autism.
What could go wrong
This is a small, early-stage trial, and results may not apply broadly. Probiotics can cause mild digestive upset, and the benefit over placebo is unproven.

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

41 people

The number who actually took part.

Started

Jul 2022

Finished

Apr 2024

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

7 to 12 years

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: * (1) Age 7 to 12 years old. * (2) PS128 group and placebo group: Children with autism spectrum disorder, confirmed by Autism Diagnostic Observation Schedule. * (3) Normal control group: Children without autism spectrum disorder. Exclusion Criteria: * (1) Receiving antibiotics within one month. * (2) Probiotics used in powder, capsule, or tablet in two weeks (except for Yogurt, Yogurt, Yakult and other related foods). * (3) Patients with hepatobiliary gastrointestinal tract who have undergone surgery (except for hernia surgery and appendectomy) * (4) Those with special diets (gluten-free, casein-free, high-protein, and ketogenic diet). * (5) Those with a history of cancer. * (6) Those who are allergic to lactic acid bacteria. * (7) Not eligible judged by PI

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

Autism spectrum disorder

Contacts and locations

Locations

  • Chang Gung Memorial Hospital

    Taoyuan, Taiwan

More trials for these conditions

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