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Poop pills or scope: can donor stool tame ulcerative colitis?

NCT ID NCT07154784

Disease control Sponsor: Seoul National University Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests fecal microbiota transplantation (FMT) in 30 people with mild-to-moderate ulcerative colitis. Participants receive donor stool either through a colonoscopy or as capsules at weeks 0 and 4. The goal is to see if FMT can help achieve steroid-free remission and improve symptoms over 48 weeks, while also checking for safety.

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) – donor stool given via colonoscopy or capsules
What this could lead to
If it works, this could offer a way to control ulcerative colitis without long-term steroids, possibly reducing flare-ups and improving quality of life.
What could go wrong
This is a small, early-phase study with only 30 participants. The treatment may not work for everyone, and there are risks of infection or worsening symptoms from the transplant.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 30 people

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

Started

Jul 2023

Expected to finish

Jun 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

10 to 80 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: * Age between 10 and 80 years * History of ulcerative colitis for at least 3 months * Mild to moderate ulcerative colitis with a Mayo score of 4-10 or a partial Mayo score of 2-7 * Endoscopic evidence of rectal involvement extending at least 5 cm * Willingness to provide written informed consent for participation in this clinical trial Exclusion Criteria: * Hospitalization due to acute severe ulcerative colitis (Mayo score 11-12) * Neutropenia (absolute neutrophil count \< 500) * Pregnancy * Infectious colitis not caused by Clostridioides difficile * History of colectomy (excluding appendectomy) * History of antibiotic use within the past 2 weeks * Use of corticosteroids \> 20 mg within the past 4 weeks * Current or planned use of biologics (e.g., anti-TNF-α antibodies, anti-α4β7 integrin monoclonal antibodies, JAK inhibitors, anti-IL-12/IL-23 antibodies) * Major food allergy * Indeterminate colitis * Comorbid chronic diseases such as chronic liver disease, heart failure, or chronic obstructive pulmonary disease (COPD) * Refusal to participate in the study * Any other condition deemed inappropriate for study participation by the investigator

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Fecal microbiota transplantation Ulcerative colitis

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine

    Seoul, Dongjak-gu, 07061, South Korea

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