Fecal Microbiota Transplantation to Prevent Complications After Stem Cell Transplantation
Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies
This study is testing whether giving a special stool treatment can help prevent complications like Graft-versus-Host Disease in patients receiving stem cell transplants for blood cancers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 20 sites (Amiens and 19 other locations) |
| Trial ID | NCT04935684 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older undergoing myelo-ablative allo-HSCT for controlled hematologic malignancies.
Not a fit: Patients with tumor progression at the time of allo-HSCT or those with serious uncontrolled diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of Graft-versus-Host Disease and improve overall survival rates in patients undergoing stem cell transplantation.
How similar studies have performed: While the approach of using FMT in this context is novel, preliminary studies have suggested potential benefits in related areas, indicating a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amiens and 19 other locations
- 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)
- Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
- Service hématologie CHU Grenoble — Grenoble, France (Not_yet_recruiting)
- Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille — Lille, France (Not_yet_recruiting)
- Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges — Limoges, France (Not_yet_recruiting)
- Service d'Hématologie Centre Hospitalier Lyon Sud — Lyon, France (Not_yet_recruiting)
- Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy — Nancy, France (Not_yet_recruiting)
- Service d'Hématologie Clinique CHU Nantes — Nantes, France (Not_yet_recruiting)
- Service d'hématologie clinique, département de greffe de moelle CHU Nice — Nice, France (Not_yet_recruiting)
- Service d'Hématologie Adultes Hôpital Necker — Paris, France (Not_yet_recruiting)
- Service d'Hématologie clinique Hôpital Pitié-Salpêtrière — Paris, France (Not_yet_recruiting)
- Service d'hématologie greffe Hôpital St Louis — Paris, France (Not_yet_recruiting)
- Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque — Pessac, France (Not_yet_recruiting)
- Service d'hématologie greffe Hôpital St Louis — Poitiers, France (Not_yet_recruiting)
- Département d'hématologie CAC Rouen — Rouen, France (Not_yet_recruiting)
- Hématologie clinique Institut de Cancérologie de la Loire — Saint-Etienne, France (Not_yet_recruiting)
- IUC T - Oncopôle — Toulouse, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.