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Clinical Trial Summary

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.


Clinical Trial Description

The TMF-Allo study is a prospective, open-label, multi-center, parallel, randomized phase II clinical trial comparing a group patients with FMT and a control group of patients without FMT. The main objective of this study is to assess the effect of allogeneic FMT versus no treatment on Graft-versus-host disease and Relapse-Free Survival (GRFS) at one year in adult patients treating with myelo-ablative allo-HSCT for haematologic malignancy. The secondary objectives are to evaluate : - Overall survival, progression-free survival at 1 and 2 years, - The haematological evolution, - The evolution of infections, - The tolerance and safety of the TMF carried out in post-transplant, - The evolution of the composition and diversity of the microbiota in allograft patients receiving TMF or not. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04935684
Study type Interventional
Source University Hospital, Clermont-Ferrand
Contact Lise LACLAUTRE
Phone +33473754963
Email promo_interne_drci@chu-clermontferrand.fr
Status Recruiting
Phase Phase 2
Start date December 20, 2022
Completion date December 2027

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