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Poop pills to prevent transplant rejection? new trial tests fecal transplants in blood cancer patients

NCT ID NCT04935684

Prevention Sponsor: University Hospital, Clermont-Ferrand 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Updated 1 time

Summary

This study tests whether a fecal microbiota transplant (FMT) can prevent graft-versus-host disease (GvHD) in 150 adults with blood cancers who receive a stem cell transplant. Patients get a single FMT enema within four weeks of transplant. The main goal is to see if FMT improves survival without GvHD or relapse one year later.

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) given as an enema
What this could lead to
If it works, this could offer a simple way to prevent serious complications after stem cell transplants, improving survival and quality of life for blood cancer patients.
What could go wrong
This is a mid-stage trial with 150 people, so results are not yet proven. FMT carries a small risk of infection or side effects, and the benefit may not be seen in all patients.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

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

Started

Dec 2022

Expected to finish

May 2030

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 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: * Patient aged 18 or over * Men and women * Patients affiliated with a social-security organization * Patients undergoing a myelo-ablative allo-HSCT for a controlled haematologic malignant disease, with peripheral stem cells, whatever the type of donor (except cord blood) * Signed and dated informed consent Exclusion Criteria: * Status of tumor progression at the time of allo-HSCT * Inability to understand the protocol (linguistic barrier, cognitive difficulties) * Medical history of another progressive cancer or occurrence in the 3 previous years (excluding basal cell carcinoma) * Presence of a simultaneous serious and uncontrolled disease (severe cardiac, renal, hepatic or respiratory failure, severe sepsis) * Fecal incontinence * Participation in another clinical trial studying an allograft procedure including the type of graft, the type of immunosuppression, a preventive or a curative treatment of GvHD, or studying the effectiveness of a FMT in another indication. * Pregnant women * Patient under guardianship, curatorship or protection of justice

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Conditions

The condition(s) this trial relates to.

acute leukemia B-cell chronic lymphocytic leukemia hematopoietic and lymphoid system neoplasm Hodgkins lymphoma lymphoma, non-Hodgkin, familial myelodysplastic syndrome Myelodysplastic Syndromes myeloproliferative neoplasm non-Hodgkin lymphoma plasma cell myeloma plasma cell neoplasm graft versus host disease prevention target

As listed by the trial registrant

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

Acute leukemia in remission Chronic lymphocytic leukemia Hodgkin lymphoma Lymphoma, non-Hodgkin Myelodysplastic syndromes Myeloma Myeloproliferative syndrome

How to take part

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

  1. The places running it

    20 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

  • Département d'hématologie CAC Rouen

    NOT_YET_RECRUITING

    Rouen, France

  • Hématologie clinique CHU Besançon

    NOT_YET_RECRUITING

    Besançon, France

  • Hématologie clinique Institut de Cancérologie de la Loire

    NOT_YET_RECRUITING

    Saint-Etienne, France

  • Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque

    NOT_YET_RECRUITING

    Pessac, France

  • IUC T - Oncopôle

    NOT_YET_RECRUITING

    Toulouse, France

  • Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • Service Maladies du sang CHU Angers

    NOT_YET_RECRUITING

    Angers, France

  • Service d'Hématologie Adultes Hôpital Necker

    RECRUITING

    Paris, France

  • Service d'Hématologie Centre Hospitalier Lyon Sud

    NOT_YET_RECRUITING

    Lyon, France

  • Service d'Hématologie Clinique CHU Nantes

    NOT_YET_RECRUITING

    Nantes, France

  • Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud

    NOT_YET_RECRUITING

    Amiens, France

  • Service d'Hématologie clinique Hôpital Pitié-Salpêtrière

    NOT_YET_RECRUITING

    Paris, France

  • Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy

    NOT_YET_RECRUITING

    Nancy, France

  • Service d'hématologie clinique, département de greffe de moelle CHU Nice

    NOT_YET_RECRUITING

    Nice, France

  • Service d'hématologie greffe Hôpital St Louis

    NOT_YET_RECRUITING

    Paris, France

  • Service d'hématologie greffe Hôpital St Louis

    NOT_YET_RECRUITING

    Poitiers, France

  • Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

  • Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges

    RECRUITING

    Limoges, France

  • Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille

    NOT_YET_RECRUITING

    Lille, France

  • Service hématologie CHU Grenoble

    NOT_YET_RECRUITING

    Grenoble, France

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