Acute Leukemia in RemissionPhase 2TMF-AlloNCT04935684
Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
A Phase 2 study testing Fecal Microbiota Transplantation in people with Acute Leukemia in Remission and Myelodysplastic Syndromes, run by University Hospital, Clermont-Ferrand at 20 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia in Remission, Myelodysplastic Syndromes, Myeloproliferative Syndrome
- What is being tested?
- Fecal Microbiota Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 20 sitesFrance
- Study dates
- 20 Dec 2022to May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 20 recruiting
- Not yet recruiting
Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud
Amiens
Magalie Magalie, MD
Magalie Magalie, MD
- Not yet recruiting
Service Maladies du sang CHU Angers
Angers
Sylvie François, MD
Sylvie François, MD
- Not yet recruiting
Hématologie clinique CHU Besançon
Besançon
Etienne Daguindau, MD
Etienne Daguindau, MD
- Recruiting
Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand
Clermont-Ferrand
Christian Dualé, MD, PhD
Christian Dualé, MD, PhD
- Not yet recruiting
Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand
Clermont-Ferrand
Jacques-Olivier Bay, MD, PhD
Jacques-Olivier Bay, MD, PhD
- Not yet recruiting
Service hématologie CHU Grenoble
Grenoble
Claude-Eric Bulabois, MD
Claude-Eric Bulabois, MD
- Not yet recruiting
Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille
Lille
David Beauvais, MD
David Beauvais, MD
- Recruiting
Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges
Limoges
Pedro DE LIMA PRATA, MD
Pedro DE LIMA PRATA, MD
- Not yet recruiting
Service d'Hématologie Centre Hospitalier Lyon Sud
Lyon
Marie-Virginie Larcher, MD
Marie-Virginie Larcher, MD
- Not yet recruiting
Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy
Nancy
Marie-Therese Rubio, MD
Marie-Therese Rubio, MD
- Not yet recruiting
Service d'Hématologie Clinique CHU Nantes
Nantes
Patrice Chevallier, MD
Patrice Chevallier, MD
- Not yet recruiting
Service d'hématologie clinique, département de greffe de moelle CHU Nice
Nice
Michel Loschi, MD
Michel Loschi, MD
- Recruiting
Service d'Hématologie Adultes Hôpital Necker
Paris
felipe Suarez, PU-PH
Ambroise Marçais, MD
- Not yet recruiting
Service d'Hématologie clinique Hôpital Pitié-Salpêtrière
Paris
Stéphanie Nguyen, MD, PhD
Stéphanie Nguyen, MD, PhD
- Not yet recruiting
Service d'hématologie greffe Hôpital St Louis
Paris
Marie Robin, MD
Marie Robin, MD
- Not yet recruiting
Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque
Pessac
Carmen Botella Garcia, MD
Carmen Botella Garcia, MD
- Not yet recruiting
Service d'hématologie greffe Hôpital St Louis
Poitiers
Deborah Desmier, MD
Deborah Desmier, MD
- Not yet recruiting
Département d'hématologie CAC Rouen
Rouen
Anne-Lise Menard, MD
Anne-Lise Menard, MD
- Not yet recruiting
Hématologie clinique Institut de Cancérologie de la Loire
Saint-Etienne
Emmanuelle Tavernier, MD
Emmanuelle Tavernier, MD
- Not yet recruiting
IUC T - Oncopôle
Toulouse
Anne Huynh, MD
Anne Huynh, MD
About this study
Official title: Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies
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.
Read the 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
- Being tested
- Fecal Microbiota Transplantation
- Keywords
- Allogeneic hematopoietic stem cell transplantation, Hematologic malignancies, Graft versus Host Disease, Intestinal microbiota, Intestinal dysbiosis, Fecal Microbiota Transplantation
- Medical subject headings
- Myelodysplastic Syndromes, Hodgkin Disease, Lymphoma, Non-Hodgkin, Neoplasms, Plasma Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Neoplasms, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Fecal Microbiota Transplantation (FMT) | Experimental | Patients 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. Receives: Drug: Fecal Microbiota Transplantation |
| Group 2: no intervention | No intervention | The 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at Day 360 after allogeneic hematopoietic stem cell transplantation
Secondary outcomes (20)
Overall survival
Overall survival is defined as the time period between the date of randomization and the date of death, regardless of its cause.
Measured: At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Progression-free survival
Progression-free survival is defined as the time period between the date of randomization and the date of disease relapse or progression or death, regardless of its cause.
Measured: At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Haematopoietic reconstitution
Haematopoietic reconstitution is assessed by: 1/ turnaround time of polynuclear neutrophils >0.5.10^9/L (first day within a period of three consecutive days); 2/ spontaneous platelet turnaround time >20.10^9/L (two days with no platelet transfusion within the previous three days); 3/ spontaneous platelet turnaround time >50.10^9/L (two days with no platelet transfusion within the previous three days); 4/ the number of transfusions of red blood cells and platelets between D0 and D100
Measured: At the time of haematopoietic reconstitution
Engraftment rates
Engraftment rates are evaluated by a chimerism measure (by molecular biology)
Measured: 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
Acute GvHD severity is defined according to MAGIC criteria. It will be notified by specifying the location (liver, skin, gut …), the severity score (II to IV), the treatment applied and the efficacy of treatment. GvHD occurrence will be notified every week until D30 (minimum) or until hospital discharge, then monthly until D180 and at D270, D360, D540 and D720.
Measured: At Day 360 after allogeneic hematopoietic stem cell transplantation
Cumulative incidence of chronic GvHD
Chronic GvHD severity will be defined according to NIHCC criteria. It will be notified by specifying the location (liver, skin, gut …), the severity score (II to IV), the treatment applied and the efficacy of treatment. GvHD occurrence will be notified every week until ungraftment, then monthly until D180 and at D270, D360, D540 and D720.
Measured: At Day 720 after allogeneic hematopoietic stem cell transplantation
Transplant-Related Mortality
Transplant-related mortality is defined as death due to causes unrelated to the underlying disease.
Measured: At Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Cumulative incidence of infections
Infectious complications will be notified every week up to day 30 (minimum) or until hospital discharge, then every month up to D180 and from D270 to D360, according to the existence of a documented bacteraemia, germ resistance, type and number of days of curative antibiotherapy used; the existence of a documented fungal infection and the type and number of days of curative antifungal treatment; the existence of a documented viral infection and the type and number of days of curative antiviral treatment; the need of an intensive care unit transfer due to an infectious complication.
Measured: At Day 360 after allogeneic hematopoietic stem cell transplantation
Severe infections description
Severe infections will be defined according to GREFIG score : bactearemia with severe sepsis, complex bactearemia (with deep organ involvement), candidemia (at least one positive blood culture) with sepsis or deep infected site, proven or probable aspergillosis pneumonia, severe varicella-zoster virus infection (involvement of a deep organ or associated coagulopathy), any viral encephalitis, CMV infection with lung or digestive location, Pneumocystis jiroveci pneumonia, toxoplasmosis with involvement of organ or central nervous system, any acute pneumonia with PaO2 less than or equal to 65mmHg, any sepsis requiring transfer to an intensive care unit.
Measured: From the day of inclusion to Day 360 after allogeneic hematopoietic stem cell transplantation
Impact of Fecal Microbiota Transplantation (FMT) on multi-resistant bacteria, extended-spectrum beta-lactamases and Clostridium difficile infection
Impact of FMT on multi-resistant bacteria, extended-spectrum beta-lactamases and Clostridium difficile infection will be assessed by evaluation of persistence or disappearance of these pathogenic bacteria after FMT.
Measured: At Day 360 after allogeneic hematopoietic stem cell transplantation
Unexpected event description that could be in relation with FMT of Fecal Microbiota Transplantation (FMT)
Each unexpected event that could be in relation with FMT will be notified: abdominal pain, diarrhea, bacterial translocation or any adverse effect attributed to the enema.
Measured: From the day of FMT to Day 360 after allogeneic hematopoietic stem cell transplantation
Quality of life assessment
The quality of life will be auto-evaluated by the patients using a validated questionnaire: European Organisation for Research and Treatment of Cancer- Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: at Day -7, Day 30, Day 90, Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Analysis the intestinal microbiota in patients
The intestinal microbiota composition and diversity will be assessed by 16S-rRNA sequencing performed prospectively in all patients with FMT and without FMT.
Measured: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Analysis the intestinal microbiota in stool donnors
The intestinal microbiota composition and diversity will be assessed by 16S-rRNA sequencing performed prospectively in all stool donnors.
Measured: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Blood collection for a metabolomic study in patients
A blood collection will be set up from blood samples collected on patients from both groups. These samples will be used for a metabolomic study (tryptophan, indoleamine 2,3-dioxygenase, short chain fatty acid, bile acids).
Measured: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Blood collection for an analysis of anti-microbiota IgG and IgA in patients
A blood collection will be set up from blood samples collected on patients from both groups. These samples will be used for an analysis of anti-microbiota IgG and IgA.
Measured: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Blood collection for a metabolomic study in stool donnors
A blood collection will be set up from blood samples collected on stool donnors. These samples will be used for a metabolomic study (tryptophan, indoleamine 2,3-dioxygenase, short chain fatty acid, bile acids).
Measured: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Blood collection for an analysis of anti-microbiota IgG and IgA in stool donnors
A blood collection will be set up from blood samples collected on stool donnors. These samples will be used for an analysis of anti-microbiota IgG and IgA.
Measured: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Stool collection for an analysis of the virome in patients
A stool collection will be carried out from stool samples collected on patients from both groups.These samples will be used for an analysis of the virome evolution.
Measured: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Stool collection for an analysis of the virome in stool donnors
A stool collection will be carried out from stool samples collected on stool donnors.These samples will be used for an analysis of the virome evolution.
Measured: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start20 Dec 2022
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Leukemia in RemissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A group patients will receive Fecal Microbiota Transplantation (FMT) within 4 weeks following neutrophils recovery after the allogeneic hematopoietic stem cell transplantation procedure and a control group of patients will not receive FMT.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, French Society of Hematology
- Responsible party
- Sponsor
- Investigators
- Jacques-Olivier BAY, MD, PhD, Principal investigator, University Hospital, Clermont-FerrandStéphanie NGUYEN, MD, PhD, Principal investigator, Groupe hospitalier Pitié-Salpêtrière, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935684
- Sponsor's protocol ID
- PHRC N 2018 BAY
- Other IDs
- 2020-000673-24
- Acronym
- TMF-Allo
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37130682
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies
- ClinicalTrials.gov ID
- NCT04935684
- Acronym / sponsor ID
- TMF-Allo / PHRC N 2018 BAY
- Conditions
- Acute Leukemia in Remission, Myelodysplastic Syndromes, Myeloproliferative Syndrome, Hodgkin Lymphoma, Lymphoma, Non-Hodgkin, Myeloma
- Keywords
- Allogeneic hematopoietic stem cell transplantation, Hematologic malignancies, Graft versus Host Disease, Intestinal microbiota, Intestinal dysbiosis, Fecal Microbiota Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Ministry of Health, France, French Society of Hematology
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A group patients will receive Fecal Microbiota Transplantation (FMT) within 4 weeks following neutrophils recovery after the allogeneic hematopoietic stem cell transplantation procedure and a control group of patients will not receive FMT.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Fecal Microbiota Transplantation (FMT) | Experimental | Drug: Fecal Microbiota TransplantationPatients 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 intervention | –The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota TransplantationPatients 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. | Drug | Group 1: Fecal Microbiota Transplantation (FMT) |
Primary outcome
Graft-versus-host disease and Relapse-Free Survival (GRFS) rate after allogeneic hematopoietic stem cell transplantation
Time frame: at Day 360 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.
20 secondary outcomes
Overall survival
Time frame: At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Progression-free survival
Time frame: At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Haematopoietic reconstitution
Time frame: At the time of haematopoietic reconstitution
Engraftment rates
Time frame: 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
Time frame: At Day 360 after allogeneic hematopoietic stem cell transplantation
Cumulative incidence of chronic GvHD
Time frame: At Day 720 after allogeneic hematopoietic stem cell transplantation
Transplant-Related Mortality
Time frame: At Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Cumulative incidence of infections
Time frame: At Day 360 after allogeneic hematopoietic stem cell transplantation
Severe infections description
Time frame: From the day of inclusion to Day 360 after allogeneic hematopoietic stem cell transplantation
Impact of Fecal Microbiota Transplantation (FMT) on multi-resistant bacteria, extended-spectrum beta-lactamases and Clostridium difficile infection
Time frame: At Day 360 after allogeneic hematopoietic stem cell transplantation
Unexpected event description that could be in relation with FMT of Fecal Microbiota Transplantation (FMT)
Time frame: From the day of FMT to Day 360 after allogeneic hematopoietic stem cell transplantation
Quality of life assessment
Time frame: at Day -7, Day 30, Day 90, Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Analysis the intestinal microbiota in patients
Time frame: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Analysis the intestinal microbiota in stool donnors
Time frame: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Blood collection for a metabolomic study in patients
Time frame: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Blood collection for an analysis of anti-microbiota IgG and IgA in patients
Time frame: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Blood collection for a metabolomic study in stool donnors
Time frame: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Blood collection for an analysis of anti-microbiota IgG and IgA in stool donnors
Time frame: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Stool collection for an analysis of the virome in patients
Time frame: Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Stool collection for an analysis of the virome in stool donnors
Time frame: At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 37130682Douge 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.
- Individual participant dataSharing planned: Yes. 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.
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Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruiting
Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCT
Acute Lymphoblastic Leukemia, Hematopoietic Stem Cell Transplantation
Active, not recruitingPhase 2
Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial
Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacques-Olivier BAY, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
Stéphanie NGUYEN, MD, PhD principal investigator
Groupe hospitalier Pitié-Salpêtrière, Paris
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbiota Transplantation in people with Acute Leukemia in Remission and Myelodysplastic Syndromes, run by University Hospital, Clermont-Ferrand at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft-versus-host disease and Relapse-Free Survival (GRFS) rate after allogeneic hematopoietic stem cell transplantation (time frame: at Day 360 after allogeneic hematopoietic stem cell transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04935684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.