Fecal Microbiota Transplantation to Prevent Complications After Stem Cell Transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy of Fecal Microbiota Transplantation (FMT) in preventing complications, particularly Graft-versus-Host Disease (GvHD), in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) for hematologic malignancies. It is a prospective, open-label, multi-center, parallel, randomized phase II trial comparing outcomes between patients receiving FMT and those who do not. The primary objective is to assess the impact of FMT on GvHD and relapse-free survival at one year, while secondary objectives include overall survival, progression-free survival, and safety of the procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges
  Limoges, France Recruiting
• Service d'Hématologie Adultes Hôpital Necker
  Paris, France Recruiting
• Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud
  Amiens, France Not yet recruiting
• Service Maladies du sang CHU Angers
  Angers, France Not yet recruiting
• Hématologie clinique CHU Besançon
  Besançon, France Not yet recruiting

Study contacts

• Principal investigator: Jacques-Olivier BAY, MD, PhD — University Hospital, Clermont-Ferrand
• Study coordinator: Lise LACLAUTRE
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: +33473754963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.