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Could a poop transplant ease autism symptoms?

NCT ID NCT06290258

Disease control 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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether fecal microbiota transplantation (FMT) can help children and young adults with autism who also have stomach issues. FMT involves transferring healthy donor stool into the patient's gut via colonoscopy. Researchers will track changes in gut and autism symptoms, as well as emotional and behavioral improvements, in 60 participants aged 7 to 30.

What this could mean

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

Active substance
fecal microbiota transplantation (FMT)
What this could lead to
If it works, this could point toward a treatment that improves both gut and autism-related symptoms in children and young adults with autism.
What could go wrong
This is an early, small study (60 participants) with no placebo group, so results may not be conclusive. The procedure involves colonoscopy and bowel prep, which carries risks like infection or discomfort.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

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

Started

Mar 2024

Expected to finish

Jul 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

7 to 30 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: * Diagnosed by a child psychiatrist in line with DSM-5 Autism Spectrum Disorder * Combined with gastrointestinal problems, any Gastrointestinal Symptoms Rating Scale score≧3. * Age is between 7-30. * Participants who are willing to participate in the study and sign the informed consent. Exclusion Criteria: * Cases where clinical assessment cannot cooperate with fecal microbiota transplantation and examination. * Cases requiring antibiotics within 3 months before or after acceptance because of their physiological condition. * Cases requiring long-term use of proton pump inhibitors due to their physiological conditions. * Severe physical diseases, such as acute gastrointestinal diseases, severe malnutrition or underweight, immunodeficiency diseases, severe allergies or autoimmune diseases, brain injuries or severe organic brain diseases, will affect the evaluation of treatment results. * Severe mental illness, such as schizophrenia, bipolar disorder, etc. * Those who used probiotics one month before the case may affect the intestinal flora. * Pregnancy. * Cases that cannot understand the content of this research. * Participants who are unwilling to participate in the study or refuse to sign the informed consent. * Participants who are not suitable to include in this study, evaluate by PI or Co-PI.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder digestive system disorder

As listed by the trial registrant

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

Autism spectrum disorder Gastrointestinal diseases Healthy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Wei-Chih Chin

    RECRUITING

    Taoyuan City, 333423, Taiwan

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