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4,000-Patient study to reveal if poop transplants really work Long-Term

NCT ID NCT07261826

Disease control Sponsor: Chen QiYi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow about 4,000 people who have received a fecal microbiota transplant (FMT) — a procedure that transfers gut bacteria from a healthy donor to restore balance in the gut. It aims to see how well FMT works over 3 months, 1 year, and 5 years for conditions like recurring C. difficile infection, inflammatory bowel disease, irritable bowel syndrome, and even autism. The researchers will also track safety and side effects to help improve and standardize this treatment.

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 4,000 people

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

Started

Sep 2025

Expected to finish

Jun 2028

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

The study population consists of approximately 4,000 patients who have undergone Fecal Microbiota Transplantation (FMT) at our center. This includes a retrospective cohort of about 3,000 patients treated between January 2017 and August 2025, whose data will be collected from medical records, and a prospective cohort of about 1,000 new patients to be enrolled from September 2025 to June 2028. Participants must be ≥3 years of age and diagnosed with one of the target diseases, including but not limited to recurrent Clostridium difficile infection, inflammatory bowel disease, functional gastrointestinal disorders, and certain extra-intestinal diseases. All participants must have received at least one FMT treatment and have available baseline data. This real-world study aims to include a broad patient population reflective of routine clinical practice.

Ages

3 years and older

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: * Diagnosed with one of the target diseases. * Age ≥ 3 years. * Have received at least one Fecal Microbiota Transplantation (FMT) treatment. * Availability of complete baseline and follow-up data for analysis. * Provide signed informed consent (for the prospective cohort) OR consent for the use of clinical data (for the retrospective cohort). Exclusion Criteria: * Clinical data is severely missing, making efficacy assessment impossible. * Presence of severe complications that may jeopardize safety or confound the study results.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder Clostridium difficile colitis constipation disorder Crohn disease intestinal obstruction irritable bowel syndrome ulcerative colitis

As listed by the trial registrant

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

Autism spectrum disorder Chemotherapy-induced colitis Chronic functional constipation Clostridium difficile infection recurrence Crohn disease (CD) Incomplete intestinal obstruction Irritable bowel syndrome (IBS) PD-1 associated enteritis Ulcerative colitis (UC)

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

  • Shanghai Tenth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200072, China

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