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Study on Fecal Microbiota Transplantation to Prevent Complications in Patients After Stem Cell Transplant for Blood Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) for treating various blood cancers. The study is investigating the use of a treatment called Fecal Microbiota Transplantation (FMT), which involves transferring healthy bacteria from a donor's stool to the patient's gut. This treatment is given as a rectal suspension, meaning it is administered through the rectum.

The purpose of the study is to see if FMT can help prevent complications after the stem cell transplant. Specifically, the study aims to improve the chances of patients staying free from a condition called graft-versus-host disease (GVHD) and cancer relapse for one year after their transplant. GVHD is a condition where the donor's immune cells attack the patient's body. The study will compare the effects of FMT with no additional treatment to see if it makes a difference in patient outcomes.

Participants in the study will receive the FMT treatment and be monitored over time to assess their health and any side effects. The study will look at various factors, including overall survival, the occurrence of infections, and the quality of life of the patients. The goal is to determine if FMT can be a safe and effective way to support patients after their stem cell transplant and improve their long-term health.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, ensure that all necessary consent forms are signed. Participation is confirmed once eligibility criteria are met, including having undergone an allogeneic hematopoietic stem cell transplantation for a controlled blood-related cancer and being 18 years or older.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current health status. This includes reviewing your medical history and any recent treatments you have received.

  3. Step 3

    Treatment administration

    The treatment involves the administration of a **fecal microbiota transplant**. This is a rectal suspension containing **allogeneic fecal microbiota**. The procedure is performed rectally, meaning it is introduced into the body through the rectum.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up appointments will be scheduled to monitor your health and the effects of the treatment. These appointments will assess the **graft-versus-host disease-free, relapse-free survival** at one year post-transplant.

    Additional evaluations will include overall survival, progression-free survival, and the incidence of any infectious complications. The safety and tolerance of the treatment will also be assessed.

  5. Step 5

    Final assessment

    A final assessment will be conducted to evaluate the overall outcomes of the treatment. This includes the evolution of the composition and diversity of your microbiota and an assessment of your quality of life.

Who can join the trial?

6 criteria

  • Patients who have had an allogeneic hematopoietic stem cell transplantation (allo-HSCT) for a controlled blood-related cancer. This means they received stem cells from a donor to treat their cancer.
  • Patients who are 18 years old or older.
  • Patients who are part of a social security organization. This means they have some form of health insurance or social health coverage.
  • Patients who have signed an informed consent. This means they have agreed to participate in the study after being informed about it.
  • Patients who have received myeloablative conditioning. This is a strong treatment given before the stem cell transplant to prepare the body.
  • Patients who have received an allogeneic peripheral stem cell transplant, which means the stem cells came from a donor, but not from cord blood.

Who cannot join the trial?

4 criteria

  • Patients who have not undergone Allogeneic hematopoietic stem cell transplantation (allo-HSCT). This is a procedure where a patient receives blood-forming stem cells from a genetically similar, but not identical, donor.
  • Patients who have not been treated with myeloablative conditioning (MAC). This is a strong treatment given before a stem cell transplant to destroy cancer cells and make room for new stem cells.
  • Patients who are not suffering from haematological malignancy. This refers to cancers that begin in blood-forming tissue, such as leukemia, lymphoma, and myeloma.
  • Patients who are part of a vulnerable population. This means groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with mental disabilities.
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Investigated drugs

Fecal Microbiota Transplantation (FMT) is a therapy that involves transferring stool from a healthy donor into the gastrointestinal tract of a patient. The goal of this treatment is to restore the balance of bacteria in the patient's gut. In this clinical trial, FMT is being used to see if it can help prevent complications after a type of stem cell transplant used to treat blood cancers. The idea is that by improving gut health, FMT might reduce the risk of certain complications that can occur after the transplant.

What is already known about the treatment

Fecal Microbiota Transplantation (FMT) – Fecal Microbiota Transplantation is administered through the introduction of processed stool from a healthy donor into the gastrointestinal tract of a patient, typically via colonoscopy, enema, or oral capsules. Currently, FMT is being explored in clinical trials for its potential to prevent complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with blood-related cancers. The main therapeutic indication is to improve survival without complications like graft-versus-host disease after stem cell transplants. At the molecular level, FMT works by restoring a healthy balance of gut bacteria, which can help regulate the immune system and reduce inflammation. It is classified under microbiota-based therapies, focusing on the beneficial effects of gut bacteria on health.

Investigated diseases

Graft-versus-host disease – This condition occurs when donor immune cells attack the recipient's body after an allogeneic hematopoietic stem cell transplantation. It primarily affects the skin, liver, and gastrointestinal tract. The disease can manifest as acute or chronic, with acute symptoms appearing within the first 100 days post-transplant. Acute symptoms include skin rashes, liver dysfunction, and gastrointestinal issues like diarrhea. Chronic graft-versus-host disease may develop later and can affect multiple organs, leading to symptoms such as dry eyes, joint pain, and skin thickening. The progression varies, with some cases resolving over time while others may persist or worsen.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512969-14-01Protocol codePHRC N 2018 BAYEstimated enrolment165 patientsSponsorCHU Gabriel-Montpied

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