Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Fecal Microbiota Transplantation (FMT)

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.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type DRUG

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.

Group 2: 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques-Olivier BAY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Stéphanie NGUYEN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe hospitalier Pitié-Salpêtrière, Paris

Locations

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