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NCT04935684
Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
Conditions: Acute Leukemia in Remission, Myelodysplastic Syndromes, Myeloproliferative Syndrome, Hodgkin Lymphoma, Lymphoma, Non-Hodgkin, Myeloma, Chronic Lymphocytic Leukemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 150
Sponsor: University Hospital, Clermont-Ferrand
Location: Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud Amiens
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 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
Source: ClinicalTrials.gov (NCT04935684). StuddyBuddy aggregates publicly available trial information.