Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation

Last updated: January 14, 2025
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Transplantation

Treatment

Fecal microbiota transplantation (FMT)

Clinical Study ID

NCT06782880
FMT-OLT
Bando RF-2021-12373311
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The increasing emergence and spread of MDRB represents a major public health problem, with higher mortality in patients experiencing infections. Cirrhotic patients listed for OLT and after OLT are at high risk of MDRB colonization or infection due to the large use of broad-spectrum antibiotics in the post-transplant setting. Therefore, effective decolonization strategies in this particular setting are urgently needed. The investigators hypothesize that heterologous FMT can reduce infections rates in the pre-and post- OLT setting by MDRB decolonization and restoration of a more physiological microbiome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult (age≥18 years) patients listed for OLT for various etiologies.

  • Patient's consent to participate in the study

Exclusion

Exclusion Criteria:

  • Previous total colectomy

  • Pregnancy or breastfeeding

  • Patients on oral or intravenous antimicrobial agents

  • HIV positive and not well controlled on antiretroviral therapy, or CD4+ <200/ mm3

  • Active SARS-CoV-2 infection

  • Neutropenia <0.5X10^9/L

  • Toxic megacolon

  • Contraindications to colonoscopy

  • Any conditions for which, according to the physician, FMT endangers the patient'shealth

  • History of hypersensitivity to macrogol contained in bowel preparations.

Study Design

Total Participants: 144
Treatment Group(s): 1
Primary Treatment: Fecal microbiota transplantation (FMT)
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
May 31, 2026

Study Description

The study is a double-blind, single-center, randomized controlled trial and will be offered consecutively to every adult patient on the liver transplant list.

Enrolled patients will be randomized (1:1) and assigned to either the heterologous or autologous fecal microbiota transplantation.

The intervention of the trial is heterologous fecal microbiota transplantation, which involves the administration of fecal material from a healthy donor into the intestine of the enrolled patient. Fecal samples will be collected every three months and before each microbiota transplant for evaluation of fecal microbiota composition. Gut permeability tests will be evaluated at enrollment and after the first fecal transplantation. Moreover, clinical and microbiota assessments will be performed after liver transplantation. All other planned assessments are part of the normal course of care.

Connect with a study center

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.