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Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

NCT04935684 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-03-01

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • French Society of Hematology

    collaborator UNKNOWN

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Jacques-Olivier BAY, MD, PhD · University Hospital, Clermont-Ferrand

  • Stéphanie NGUYEN, MD, PhD · Groupe hospitalier Pitié-Salpêtrière, Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-20
Primary Completion
2026-10-31
Completion
2027-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04935684 on ClinicalTrials.gov