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Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

RECRUITINGPhase 2Sponsored by University Hospital, Clermont-Ferrand
Actively Recruiting
PhasePhase 2
SponsorUniversity Hospital, Clermont-Ferrand
Started2022-12-20
Est. completion2026-10
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions8

Acute Leukemia in RemissionCancerChronic Lymphocytic LeukemiaHodgkin LymphomaLymphoma, Non-HodgkinMyelodysplastic SyndromesMyelomaMyeloproliferative Syndrome

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