NCT06782880

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

Efficacy and Safety of Fecal Microbiota Transplantation for the Prevention of Early-onset Infectious Complications After Orthotopic Liver Transplantation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

1 site across 1 country: Italy