Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
TMF-Allo
2 other identifiers
interventional
150
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2022
Longer than P75 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedStudy Start
First participant enrolled
December 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 1, 2023
October 1, 2022
3.8 years
June 1, 2021
February 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Graft-versus-host disease and Relapse-Free Survival (GRFS) rate after allogeneic hematopoietic stem cell transplantation
GRFS is a composite endpoint of GvHD-free/relapse-free survival in which events include grade II-IV acute GvHD, moderate and severe chronic GvHD, relapse, or death in the first year post-HSCT. GRFS will be measured at one year after allo-HSCT and compared between both groups of patients.
at Day 360 after allogeneic hematopoietic stem cell transplantation
Secondary Outcomes (20)
Overall survival
At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Progression-free survival
At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Haematopoietic reconstitution
At the time of haematopoietic reconstitution
Engraftment rates
At Day 30, Day 60, Day 90, Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantationday
Cumulative incidence of acute GvHD
At Day 360 after allogeneic hematopoietic stem cell transplantation
- +15 more secondary outcomes
Study Arms (2)
Group 1: Fecal Microbiota Transplantation (FMT)
EXPERIMENTALPatients randomized in the "FMT group" will received FMT. FMT product will be made by the the pharmacy of the Clermont-Ferrand University Hospital from stools of healthy volunteer donors within 6 hours after defecation in order to preserve the viability of the bacteria. The preparation will be standardized: 50g aliquots will be prepared and diluted in 250mL of 0.9% NaCl containing 10% glycerol, until a homogeneous suspension is obtained. The preparation will be rapidly frozen at -80°C until use, with a maximum shelf life of 18 months.
Group 2: no intervention
NO INTERVENTIONThe comparator group will be constituted by patients randomized in the "no FMT" group. For ethical reasons, these patients will not receive any FMT and therefore no enema or colic preparation. No placebo will be administered. Prophylactic anti-infective treatments can be introduced at any time.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Clermont-Ferrandlead
- Ministry of Health, Francecollaborator
- French Society of Hematologycollaborator
Study Sites (20)
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
Related Publications (1)
Douge A, Ravinet A, Corriger A, Cabrespine A, Wasiak M, Pereira B, Sokol H, Nguyen S, Bay JO. Faecal microbiota transplantation to prevent complications after allogeneic stem cell transplantation for haematological malignancies: a study protocol for a randomised controlled phase-II trial (the FMT-allo study). BMJ Open. 2023 May 2;13(5):e068480. doi: 10.1136/bmjopen-2022-068480.
PMID: 37130682DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques-Olivier BAY, MD, PhD
University Hospital, Clermont-Ferrand
- PRINCIPAL INVESTIGATOR
Stéphanie NGUYEN, MD, PhD
Groupe hospitalier Pitié-Salpêtrière, Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 23, 2021
Study Start
December 20, 2022
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
March 1, 2023
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- At the end of the study, on request from the corresponding author after examining the request.
- Access Criteria
- On request from the corresponding author after examining the request.
Full protocol, participant-level data, statistical codes, trial datasets and analyses will be made available on request from the corresponding author after examining the request.