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Gut health fix for autism anxiety? small study tests synbiotic

NCT ID NCT06126185

Symptom relief Sponsor: Chinese University of Hong Kong 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested whether a 12-week course of a synbiotic supplement (probiotics plus prebiotics) could help reduce anxiety in 30 children with autism spectrum disorder. The main goals were to see if the treatment was safe and tolerable, and to measure any changes in anxiety and sensory sensitivity. Because it was a small, open-label study without a placebo group, the results are preliminary and not conclusive.

What this could mean

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

Active substance
synbiotic (probiotics and prebiotics)
What this could lead to
If it works, this could point toward a gut-based approach to ease anxiety in children with autism.
What could go wrong
This is a very small, early pilot study with no placebo group, so results may not be reliable or generalizable. Side effects are possible.

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

30 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 2025

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

2 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. ASD children of Chinese ethnicity aged \<12 with diagnosis made by child psychiatrists based on Diagnostic and Statistical Manual, Fifth Edition (DSM-5) diagnostic criteria. 2. Elevated anxiety level, as measured by Anxiety Scale for Children-Autism Spectrum Disorder (ASC-ASD) 3. Presence of sensory hyperresponsiveness, as measured by Sensory Experience Questionnaire (SEQ) Exclusion Criteria: 1. Co-occurring mental retardation, neurological, psychosis, depression or other severe mental illness. 2. History of non-functional gastrointestinal disorders such as inflammatory bowel disease and Hirschsprung's disease. 3. Presence of other significant physical illness, including but not limited to: current active malignancy, immunosuppression, organ failure and epilepsy 4. Exposure to antibiotics within 1 months of the study or history of using probiotics. 5. On special diet such as being a vegetarian

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder autism spectrum disorder

As listed by the trial registrant

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

Anxiety Autism spectrum disorder

Contacts and locations

Locations

  • The Chinese University of Hong Kong

    Hong Kong, Hong Kong

More trials for these conditions

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