Fecal Microbiota Transplantation to Prevent Early Infections After Orthotopic Liver Transplantation A Randomized Controlled Study

What this Trial Is About

Researchers are investigating the use of fecal microbiota transplantation (FMT) to prevent infections in adult patients undergoing orthotopic liver transplantation (OLT). Cirrhotic patients listed for and after OLT are at high risk of colonization or infection by multi-drug resistant bacteria (MDRB) due to extensive use of broad-spectrum antibiotics. The study aims to evaluate whether heterologous FMT, which uses fecal material from healthy donors, is more effective than autologous FMT in reducing major infection episodes within six months after OLT by restoring a healthier gut microbiome. This is a double-blind, single-center, randomized controlled trial where adult patients on the liver transplant list will be randomly assigned to receive either heterologous or autologous FMT. The heterologous FMT involves administering fecal material from a healthy donor into the patient's intestine. Fecal samples will be collected every three months and before each transplant to assess microbiota composition. Gut permeability tests will be done at enrollment and after the first FMT. Clinical and microbiota assessments will continue after liver transplantation as part of routine care. Participants will undergo regular monitoring including fecal microbiota evaluations and gut permeability tests. Researchers will measure the rate of major infection episodes within six months after liver transplantation to compare the effectiveness of the two FMT approaches. All other assessments will follow standard care protocols. The study focuses on safety and preventing early infections in patients receiving liver transplants.

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