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Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation
Sponsor: University Hospital, Clermont-Ferrand
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.
Official title: Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2022-12-20
Completion Date
2027-12
Last Updated
2023-03-01
Healthy Volunteers
No
Conditions
Interventions
Fecal Microbiota Transplantation
Patients randomized in the "FMT group" will received FMT within 4 weeks following neutrophils recovery after the allo-HSCT procedure. The stool transplant will be done by enema. The day before FMT, patient will undergo bowel cleansing by ingestion of two liters of polyethylene glycol solution. The day of FMT, a colon cleanse enema will be performed in the morning and FMT will be delivered around two hours after the cleanse enema. This colic preparation is essential to optimize the results of FMT. The enema (50g of stools diluted in 250mL of NaCl 0.9%) will be performed by a qualified member of the study team (nurse) by using a rectal cannula (within 6 hours of thawing). The enema will have to be kept by the patient for as long as possible and at least 30 minutes.
Locations (20)
Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud
Amiens, France
Service Maladies du sang CHU Angers
Angers, France
Hématologie clinique CHU Besançon
Besançon, France
Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand
Clermont-Ferrand, France
Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand
Clermont-Ferrand, France
Service hématologie CHU Grenoble
Grenoble, France
Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille
Lille, France
Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges
Limoges, France
Service d'Hématologie Centre Hospitalier Lyon Sud
Lyon, France
Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy
Nancy, France
Service d'Hématologie Clinique CHU Nantes
Nantes, France
Service d'hématologie clinique, département de greffe de moelle CHU Nice
Nice, France
Service d'Hématologie Adultes Hôpital Necker
Paris, France
Service d'Hématologie clinique Hôpital Pitié-Salpêtrière
Paris, France
Service d'hématologie greffe Hôpital St Louis
Paris, France
Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque
Pessac, France
Service d'hématologie greffe Hôpital St Louis
Poitiers, France
Département d'hématologie CAC Rouen
Rouen, France
Hématologie clinique Institut de Cancérologie de la Loire
Saint-Etienne, France
IUC T - Oncopôle
Toulouse, France