Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

• Status: Not yet recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: French Society of Hematology; Ministry of Health, France

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