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Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation (TMF-Allo)

Primary Purpose

Acute Leukemia in Remission, Myelodysplastic Syndromes, Myeloproliferative Syndrome

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia in Remission focused on measuring Allogeneic hematopoietic stem cell transplantation, Hematologic malignancies, Graft versus Host Disease, Intestinal microbiota, Intestinal dysbiosis, Fecal Microbiota Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1: Fecal Microbiota Transplantation (FMT)

Group 2: no intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival
Overall survival is defined as the time period between the date of randomization and the date of death, regardless of its cause.
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.
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
Engraftment rates
Engraftment rates are evaluated by a chimerism measure (by molecular biology)
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.
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.
Transplant-Related Mortality
Transplant-related mortality is defined as death due to causes unrelated to the underlying disease.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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).
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.
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.
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.

Full Information

First Posted
June 1, 2021
Last Updated
February 28, 2023
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Ministry of Health, France, French Society of Hematology
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1. Study Identification

Unique Protocol Identification Number
NCT04935684
Brief Title
Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
Acronym
TMF-Allo
Official Title
Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Ministry of Health, France, French Society of Hematology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia in Remission, Myelodysplastic Syndromes, Myeloproliferative Syndrome, Hodgkin Lymphoma, Lymphoma, Non-Hodgkin, Myeloma, Chronic Lymphocytic Leukemia
Keywords
Allogeneic hematopoietic stem cell transplantation, Hematologic malignancies, Graft versus Host Disease, Intestinal microbiota, Intestinal dysbiosis, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Fecal Microbiota Transplantation (FMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: no intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Graft-versus-host disease and Relapse-Free Survival (GRFS) rate after allogeneic hematopoietic stem cell transplantation
Description
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.
Time Frame
at Day 360 after allogeneic hematopoietic stem cell transplantation
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is defined as the time period between the date of randomization and the date of death, regardless of its cause.
Time Frame
At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Title
Progression-free survival
Description
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.
Time Frame
At Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Title
Haematopoietic reconstitution
Description
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
Time Frame
At the time of haematopoietic reconstitution
Title
Engraftment rates
Description
Engraftment rates are evaluated by a chimerism measure (by molecular biology)
Time Frame
At Day 30, Day 60, Day 90, Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantationday
Title
Cumulative incidence of acute GvHD
Description
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.
Time Frame
At Day 360 after allogeneic hematopoietic stem cell transplantation
Title
Cumulative incidence of chronic GvHD
Description
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.
Time Frame
At Day 720 after allogeneic hematopoietic stem cell transplantation
Title
Transplant-Related Mortality
Description
Transplant-related mortality is defined as death due to causes unrelated to the underlying disease.
Time Frame
At Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Title
Cumulative incidence of infections
Description
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.
Time Frame
At Day 360 after allogeneic hematopoietic stem cell transplantation
Title
Severe infections description
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.
Time Frame
From the day of inclusion to Day 360 after allogeneic hematopoietic stem cell transplantation
Title
Impact of Fecal Microbiota Transplantation (FMT) on multi-resistant bacteria, extended-spectrum beta-lactamases and Clostridium difficile infection
Description
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.
Time Frame
At Day 360 after allogeneic hematopoietic stem cell transplantation
Title
Unexpected event description that could be in relation with FMT of Fecal Microbiota Transplantation (FMT)
Description
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.
Time Frame
From the day of FMT to Day 360 after allogeneic hematopoietic stem cell transplantation
Title
Quality of life assessment
Description
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.
Time Frame
at Day -7, Day 30, Day 90, Day 180, Day 360 and Day 720 after allogeneic hematopoietic stem cell transplantation
Title
Analysis the intestinal microbiota in patients
Description
The intestinal microbiota composition and diversity will be assessed by 16S-rRNA sequencing performed prospectively in all patients with FMT and without FMT.
Time Frame
Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Title
Analysis the intestinal microbiota in stool donnors
Description
The intestinal microbiota composition and diversity will be assessed by 16S-rRNA sequencing performed prospectively in all stool donnors.
Time Frame
At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Title
Blood collection for a metabolomic study in patients
Description
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).
Time Frame
Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Title
Blood collection for an analysis of anti-microbiota IgG and IgA in patients
Description
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.
Time Frame
Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Title
Blood collection for a metabolomic study in stool donnors
Description
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).
Time Frame
At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Title
Blood collection for an analysis of anti-microbiota IgG and IgA in stool donnors
Description
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.
Time Frame
At the time of the first stool donnation between Day 7 to Day 55 after the inclusion
Title
Stool collection for an analysis of the virome in patients
Description
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.
Time Frame
Before the conditioning regimen, before the FMT and at Day 30, Day 90 and Day 360 after white blood cells recovery
Title
Stool collection for an analysis of the virome in stool donnors
Description
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.
Time Frame
At the time of the first stool donnation between Day 7 to Day 55 after the inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques-Olivier BAY, MD, PhD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stéphanie NGUYEN, MD, PhD
Organizational Affiliation
Groupe hospitalier Pitié-Salpêtrière, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud
City
Amiens
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magalie Magalie, MD
First Name & Middle Initial & Last Name & Degree
Magalie Magalie, MD
Facility Name
Service Maladies du sang CHU Angers
City
Angers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie François, MD
First Name & Middle Initial & Last Name & Degree
Sylvie François, MD
Facility Name
Hématologie clinique CHU Besançon
City
Besançon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Daguindau, MD
First Name & Middle Initial & Last Name & Degree
Etienne Daguindau, MD
Facility Name
Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Dualé, MD, PhD
First Name & Middle Initial & Last Name & Degree
Christian Dualé, MD, PhD
Facility Name
Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques-Olivier Bay, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jacques-Olivier Bay, MD, PhD
First Name & Middle Initial & Last Name & Degree
Aurélie Ravinet, MD
Facility Name
Service hématologie CHU Grenoble
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claude-Eric Bulabois, MD
First Name & Middle Initial & Last Name & Degree
Claude-Eric Bulabois, MD
Facility Name
Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Beauvais, MD
First Name & Middle Initial & Last Name & Degree
David Beauvais, MD
Facility Name
Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges
City
Limoges
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Turlure, MD
First Name & Middle Initial & Last Name & Degree
Pascal Turlure, MD
Facility Name
Service d'Hématologie Centre Hospitalier Lyon Sud
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Virginie Larcher, MD
First Name & Middle Initial & Last Name & Degree
Marie-Virginie Larcher, MD
Facility Name
Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy
City
Nancy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Therese Rubio, MD
First Name & Middle Initial & Last Name & Degree
Marie-Therese Rubio, MD
Facility Name
Service d'Hématologie Clinique CHU Nantes
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice Chevallier, MD
First Name & Middle Initial & Last Name & Degree
Patrice Chevallier, MD
Facility Name
Service d'hématologie clinique, département de greffe de moelle CHU Nice
City
Nice
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Loschi, MD
First Name & Middle Initial & Last Name & Degree
Michel Loschi, MD
Facility Name
Service d'Hématologie Adultes Hôpital Necker
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambroise Marçais, MD
First Name & Middle Initial & Last Name & Degree
Ambroise Marçais, MD
Facility Name
Service d'Hématologie clinique Hôpital Pitié-Salpêtrière
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie Nguyen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Stéphanie Nguyen, MD, PhD
Facility Name
Service d'hématologie greffe Hôpital St Louis
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Robin, MD
First Name & Middle Initial & Last Name & Degree
Marie Robin, MD
Facility Name
Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque
City
Pessac
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Botella Garcia, MD
First Name & Middle Initial & Last Name & Degree
Carmen Botella Garcia, MD
Facility Name
Service d'hématologie greffe Hôpital St Louis
City
Poitiers
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Desmier, MD
First Name & Middle Initial & Last Name & Degree
Deborah Desmier, MD
Facility Name
Département d'hématologie CAC Rouen
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Lise Menard, MD
First Name & Middle Initial & Last Name & Degree
Anne-Lise Menard, MD
Facility Name
Hématologie clinique Institut de Cancérologie de la Loire
City
Saint-Étienne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle Tavernier, MD
First Name & Middle Initial & Last Name & Degree
Emmanuelle Tavernier, MD
Facility Name
IUC T - Oncopôle
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Huynh, MD
First Name & Middle Initial & Last Name & Degree
Anne Huynh, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
At the end of the study, on request from the corresponding author after examining the request.
IPD Sharing Access Criteria
On request from the corresponding author after examining the request.

Learn more about this trial

Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

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