NCT04935684

Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Fecal Microbiota Transplantation	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.

Timeline

• Start date: 2022-12-20
• Primary completion: 2026-10-01
• Completion: 2027-12-01
• First posted: 2021-06-23
• Last updated: 2023-03-01

Locations

20 sites across 1 country: France