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RECRUITING
NCT04935684
PHASE2

Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

Sponsor: University Hospital, Clermont-Ferrand

View on ClinicalTrials.gov

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

Interventions

DRUG

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