Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies
University Hospital, Clermont-Ferrand
150 participants
Dec 20, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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
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.
Locations(20)
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NCT04935684