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Could a gut bacteria transplant ease autism symptoms? new trial aims to find out

NCT ID NCT06030752

Disease control Sponsor: The Second Hospital of Nanjing Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This early-phase trial tests whether transplanting healthy donor gut bacteria (washed microbiota transplantation) can improve autism and ADHD symptoms in 80 children aged 3-17. The approach targets the 'gut-brain axis,' since many children with autism have gut microbiome imbalances. Researchers will track changes in behavior scales and gut bacteria composition over time.

What this could mean

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

Active substance
washed microbiota transplantation (fecal microbiota transplant)
What this could lead to
If it works, this could point toward a new treatment option for autism and ADHD symptoms by restoring healthy gut bacteria.
What could go wrong
This is a very early phase 1 trial with only 80 participants, so results may not apply widely. The procedure involves transplanting donor stool, which carries unknown long-term risks.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 80 people

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

Started

Sep 2023

Expected to finish

May 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

3 to 17 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: * Children and adolescents with an established diagnosis of ADHD or ADHD + ASD according to the Diagnostic and Statistical Manual Of Mental Disorders Fifth Edition;. * Age 3-17 years. * Received stable treatments for ≥1 month preceding WMT Exclusion Criteria: * Their guardian could not understand the questionnaires or provide informed consent. * Diagnosed with a single-gene disorder, major brain malformations, gastrointestinal diseases (ulcerative colitis, Crohn's disease, or eosinophilic esophagitis) * Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases, severe infection, tumors, etc. * Accompanied with other life-threatening disorders required emergency treatment. * Unable to tolerate colonoscopy or anesthesia.

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Conditions

The condition(s) this trial relates to.

attention deficit-hyperactivity disorder autism spectrum disorder

As listed by the trial registrant

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

Autism spectrum disorder

How to take part

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

  1. The places running it

    2 sites. 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

  • Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, China

  • SIR RUN RUN hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, China

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