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Could a gut bug swap ease ADHD? early trial launches

NCT ID NCT06376331

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 4 times

Summary

This early study is testing whether a washed fecal transplant (WMT) can improve ADHD symptoms and related issues like sleep problems in children aged 3-17. The idea is that changing the gut bacteria might help the brain via the gut-brain axis. Fifty children will receive the transplant, and doctors will track changes in ADHD severity and sleep quality.

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 transplant)
What this could lead to
If it works, this could point toward a new way to treat ADHD by targeting the gut-brain connection.
What could go wrong
This is a very early Phase 1 trial with only 50 children, so it is far from proven. The treatment may not work or could cause side effects.

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.

Participants

About 50 people

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

Started

Apr 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.

Who is studied

Children with an established diagnosis of ADHD aged 3-17 years old

Ages

3 to 17 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. Children with an established diagnosis of ADHD according to Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition; 2. Aged 3-17; 3. Received stable treatments for ≥1 month preceding WMT; 4. Did not take medications affecting gut microbiota such as antibiotics and probiotics three months before WMT. Exclusion Criteria: 1. Unable to understand the questionnaires or provide informed consent by the guardian; 2. Diagnosed with a single-gene disorder, psychosis, central nervous system diseases, gastrointestinal diseases including ulcerative colitis, Crohn's disease, celiac disease, or eosinophilic esophagitis; 3. Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases and cancer; 4. Accompanied with other life-threatening disorders required emergency treatment; 5. Unable to tolerate colonoscopy or anesthesia

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder Parasomnias

As listed by the trial registrant

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

Attention deficit hyperactivity 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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