Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04935684
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Clermont-Ferrand
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jacques-Olivier BAY, MD, PhDStéphanie NGUYEN, MD, PhD
Principal Investigator Affiliation University Hospital, Clermont-FerrandGroupe hospitalier Pitié-Salpêtrière, Paris
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Acute Leukemia in Remission, Myelodysplastic Syndromes, Myeloproliferative Syndrome, Hodgkin Lymphoma, Lymphoma, Non-Hodgkin, Myeloma, Chronic Lymphocytic Leukemia
Additional Details

The TMF-Allo study is a prospective, open-label, multi-center, parallel, randomized phase II clinical trial comparing a group patients with FMT and a control group of patients without FMT. The main objective of this study is to assess the effect of allogeneic FMT versus no treatment on Graft-versus-host disease and Relapse-Free Survival (GRFS) at one year in adult patients treating with myelo-ablative allo-HSCT for haematologic malignancy. The secondary objectives are to evaluate :

  • - Overall survival, progression-free survival at 1 and 2 years, - The haematological evolution, - The evolution of infections, - The tolerance and safety of the TMF carried out in post-transplant, - The evolution of the composition and diversity of the microbiota in allograft patients receiving TMF or not.

Arms & Interventions

Arms

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Amiens, France

Status

Address

Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud

Amiens, ,

Site Contact

Magalie Magalie, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Service Maladies du sang CHU Angers, Angers, France

Status

Address

Service Maladies du sang CHU Angers

Angers, ,

Site Contact

Sylvie François, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Hématologie clinique CHU Besançon, Besançon, France

Status

Address

Hématologie clinique CHU Besançon

Besançon, ,

Site Contact

Etienne Daguindau, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Clermont-Ferrand, France

Status

Address

Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand

Clermont-Ferrand, ,

Site Contact

Christian Dualé, MD, PhD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Clermont-Ferrand, France

Status

Address

Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand

Clermont-Ferrand, ,

Site Contact

Jacques-Olivier Bay, MD, PhD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Service hématologie CHU Grenoble, Grenoble, France

Status

Address

Service hématologie CHU Grenoble

Grenoble, ,

Site Contact

Claude-Eric Bulabois, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Lille, France

Status

Address

Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille

Lille, ,

Limoges, France

Status

Address

Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges

Limoges, ,

Lyon, France

Status

Address

Service d'Hématologie Centre Hospitalier Lyon Sud

Lyon, ,

Site Contact

Marie-Virginie Larcher, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Nancy, France

Status

Address

Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy

Nancy, ,

Site Contact

Marie-Therese Rubio, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Nantes, France

Status

Address

Service d'Hématologie Clinique CHU Nantes

Nantes, ,

Site Contact

Patrice Chevallier, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Nice, France

Status

Address

Service d'hématologie clinique, département de greffe de moelle CHU Nice

Nice, ,

Paris, France

Status

Address

Service d'Hématologie Adultes Hôpital Necker

Paris, ,

Site Contact

Ambroise Marçais, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Paris, France

Status

Address

Service d'Hématologie clinique Hôpital Pitié-Salpêtrière

Paris, ,

Site Contact

Stéphanie Nguyen, MD, PhD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Paris, France

Status

Address

Service d'hématologie greffe Hôpital St Louis

Paris, ,

Pessac, France

Status

Address

Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque

Pessac, ,

Site Contact

Carmen Botella Garcia, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Poitiers, France

Status

Address

Service d'hématologie greffe Hôpital St Louis

Poitiers, ,

Site Contact

Deborah Desmier, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Département d'hématologie CAC Rouen, Rouen, France

Status

Address

Département d'hématologie CAC Rouen

Rouen, ,

Site Contact

Anne-Lise Menard, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Saint-Étienne, France

Status

Address

Hématologie clinique Institut de Cancérologie de la Loire

Saint-Étienne, ,

Site Contact

Emmanuelle Tavernier, MD

promo_interne_drci@chu-clermontferrand.fr

+33473754963

IUC T - Oncopôle, Toulouse, France

Status

Address

IUC T - Oncopôle

Toulouse, ,