Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Fecal Microbiota Transplantation

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Clermont-Ferrand

Lead sponsor

Ministry of Health, France

Collaborator

French Society of Hematology

Collaborator