Efficacy and Safety of Fecal Microbiota Transplantation for Preventing Early Infections After Orthotopic Liver Transplantation

What this Trial Is About

Researchers are studying the use of fecal microbiota transplantation (FMT) to prevent infections in adult patients undergoing orthotopic liver transplantation (OLT). This study focuses on patients at high risk of infections caused by multi-drug resistant bacteria (MDRB) due to frequent use of broad-spectrum antibiotics before and after liver transplant. The goal is to evaluate whether heterologous FMT, which introduces healthy donor bacteria, can reduce infection rates and restore a healthier gut microbiome compared to autologous FMT using the patient's own stool. This is a double-blind, randomized controlled trial where participants will be assigned to receive either heterologous FMT from screened healthy donors or autologous FMT using their own stool. The fecal material will be administered by enema or colonoscopy before and after transplant. Researchers will collect fecal samples every three months and before each transplant to analyze microbiota changes. Gut permeability tests will be done at enrollment and after the first transplant. Clinical and microbiota assessments will continue after the liver transplant. Participants will be monitored for six months after liver transplantation to measure the rate of major infections, which is the main outcome. Safety will also be assessed over a three-year period to track any adverse events related to FMT. All other evaluations will follow standard care procedures. Throughout the study, stool samples, gut tests, and clinical health will be regularly checked to understand how well the treatments work and how safe they are for patients.

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