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Poop pills? no, a colonoscopy with donor stool to fight a deadly transplant complication

NCT ID NCT03819803

Disease control Sponsor: Medical University of Graz 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether putting healthy donor stool into the gut can help people with severe gut inflammation after a stem cell transplant. The condition, called gastrointestinal graft-versus-host disease, is hard to treat and often deadly. Fifteen patients will receive the stool via colonoscopy to see if it calms the inflammation and improves survival.

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 from a healthy donor
What this could lead to
If it works, this could offer a new way to control severe gut inflammation after stem cell transplants, reducing the need for strong immune-suppressing drugs.
What could go wrong
This is a very small early-phase trial with only 15 people. The treatment involves colonoscopy and carries risks like infection or complications. It may not work for everyone or lead to lasting benefits.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 15 people

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

Started

Mar 2017

Expected to finish

Dec 2026

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

18 to 70 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: * first episode of histologically confirmed, steroid-refractory GI-aGvHD * reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement * eligibility for repeated colonoscopic procedures * informed consent Exclusion Criteria: * complications during a previous colonoscopy * recurrent episode of GI-aGvHD * lacking cardiopulmonary fitness for repeated colonoscopic procedures * septic infection * acute extraintestinal organ failure (excluding bone marrow) * mechanical ileus

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

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

Graft versus host disease in gi tract

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

  • Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz

    RECRUITING

    Graz, Styria, 8036, Austria

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