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Recruiting Phase 2 NCT04935684

Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

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Trial Parameters

Condition Acute Leukemia in Remission
Sponsor University Hospital, Clermont-Ferrand
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-12-20
Completion 2026-10
Interventions
Fecal Microbiota Transplantation

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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.

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 indicatio

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