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

NCT06782880 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-01-20

No results posted yet for this 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.

Conditions

  • Fecal Microbiota Transplantation
  • Orthotopic Liver Transplantation
  • Multi-drug Resistant Bacteria

Interventions

PROCEDURE

Fecal microbiota transplantation (FMT)

To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Giovanni Barbara, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Italy

Study Locations

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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 NCT06782880 on ClinicalTrials.gov