Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies
Who is this study for? Patients with hematological malignancies
What treatments are being studied? Fecal Microbiota Transplantation
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud
NOT_YET_RECRUITING
Amiens
Service Maladies du sang CHU Angers
NOT_YET_RECRUITING
Angers
Hématologie clinique CHU Besançon
NOT_YET_RECRUITING
Besançon
Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand
RECRUITING
Clermont-ferrand
Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
Service hématologie CHU Grenoble
NOT_YET_RECRUITING
Grenoble
Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille
NOT_YET_RECRUITING
Lille
Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges
NOT_YET_RECRUITING
Limoges
Service d'Hématologie Centre Hospitalier Lyon Sud
NOT_YET_RECRUITING
Lyon
Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy
NOT_YET_RECRUITING
Nancy
Service d'Hématologie Clinique CHU Nantes
NOT_YET_RECRUITING
Nantes
Service d'hématologie clinique, département de greffe de moelle CHU Nice
NOT_YET_RECRUITING
Nice
Service d'Hématologie Adultes Hôpital Necker
NOT_YET_RECRUITING
Paris
Service d'Hématologie clinique Hôpital Pitié-Salpêtrière
NOT_YET_RECRUITING
Paris
Service d'hématologie greffe Hôpital St Louis
NOT_YET_RECRUITING
Paris
Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque
NOT_YET_RECRUITING
Pessac
Service d'hématologie greffe Hôpital St Louis
NOT_YET_RECRUITING
Poitiers
Département d'hématologie CAC Rouen
NOT_YET_RECRUITING
Rouen
Hématologie clinique Institut de Cancérologie de la Loire
NOT_YET_RECRUITING
Saint-etienne
IUC T - Oncopôle
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Lise LACLAUTRE
promo_interne_drci@chu-clermontferrand.fr
+33473754963
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2027-12
Participants
Target number of participants: 150
Treatments
Experimental: Group 1: Fecal Microbiota Transplantation (FMT)
Patients randomized in the FMT group will received FMT. FMT product will be made by the the pharmacy of the Clermont-Ferrand University Hospital from stools of healthy volunteer donors within 6 hours after defecation in order to preserve the viability of the bacteria. The preparation will be standardized: 50g aliquots will be prepared and diluted in 250mL of 0.9% NaCl containing 10% glycerol, until a homogeneous suspension is obtained. The preparation will be rapidly frozen at -80°C until use, with a maximum shelf life of 18 months.
No_intervention: Group 2: no intervention
The comparator group will be constituted by patients randomized in the no FMT group. For ethical reasons, these patients will not receive any FMT and therefore no enema or colic preparation. No placebo will be administered. Prophylactic anti-infective treatments can be introduced at any time.
Related Therapeutic Areas
Sponsors
Collaborators: Ministry of Health, France, French Society of Hematology
Leads: University Hospital, Clermont-Ferrand