RECRUITING Phase 2 ClinicalTrials.gov

Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

Sponsor: University Hospital, Clermont-Ferrand • ClinicalTrials.gov ID: NCT04935684

Registry updated: 2026-09-21

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Description

The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD). The hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.

Interventions

Fecal Microbiota Transplantation (Drug)
Patients randomized in the "FMT group" will received FMT within 4 weeks following neutrophils recovery after the allo-HSCT procedure. The stool transplant will be done by enema. The day before FMT, patient will undergo bowel cleansing by ingestion of two liters of polyethylene glycol solution. The day of FMT, a colon cleanse enema will be performed in the morning and FMT will be delivered around two hours after the cleanse enema. This colic preparation is essential to optimize the results of FMT. The enema (50g of stools diluted in 250mL of NaCl 0.9%) will be performed by a qualified member of the study team (nurse) by using a rectal cannula (within 6 hours of thawing). The enema will have to be kept by the patient for as long as possible and at least 30 minutes.

Eligibility 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

Conditions

Acute Leukemia in Remission Myelodysplastic Syndromes Myeloproliferative Syndrome Hodgkin Lymphoma Lymphoma, Non-Hodgkin Myeloma Chronic Lymphocytic Leukemia

Locations

Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud — Amiens, France
Service Maladies du sang CHU Angers — Angers, France
Hématologie clinique CHU Besançon — Besançon, France
Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand — Clermont-Ferrand, France
Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand — Clermont-Ferrand, France
Service hématologie CHU Grenoble — Grenoble, France
Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille — Lille, France
Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges — Limoges, France
Service d'Hématologie Centre Hospitalier Lyon Sud — Lyon, France
Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy — Nancy, France
Service d'Hématologie Clinique CHU Nantes — Nantes, France
Service d'hématologie clinique, département de greffe de moelle CHU Nice — Nice, France
Service d'Hématologie Adultes Hôpital Necker — Paris, France
Service d'Hématologie clinique Hôpital Pitié-Salpêtrière — Paris, France
Service d'hématologie greffe Hôpital St Louis — Paris, France
Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque — Pessac, France
Service d'hématologie greffe Hôpital St Louis — Poitiers, France
Département d'hématologie CAC Rouen — Rouen, France
Hématologie clinique Institut de Cancérologie de la Loire — Saint-Etienne, France
IUC T - Oncopôle — Toulouse, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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