Phase 3 Study of Fecal Microbiota Transplantation to Treat Patients With Decompensated Cirrhosis Using Oral Capsules

What this Trial Is About

Researchers are studying the safety and effectiveness of Fecal Microbiota Transplantation FMT in patients with decompensated cirrhosis. This is a phase III, multicenter, double-blind, placebo-controlled, randomized clinical trial comparing FMT from healthy donors to a placebo. The trial aims to evaluate whether FMT can halt the progression of decompensated cirrhosis and improve patient outcomes. Participants receive two doses of capsules the first dose of 24 FMT capsules at the start of the trial and a second dose of 24 capsules at three months. Each dose contains about 50 grams of stool for the FMT group or a placebo containing microcrystalline cellulose. Participants are randomly assigned to receive either the FMT or placebo treatment, and the study is blinded so neither participants nor researchers know the group assignments. Throughout the 12-month study period, participants will undergo regular assessments including survival without liver transplant, mortality rates, complications of cirrhosis, hospital admissions, liver function tests, inflammatory markers, microbiome analysis from saliva and stool samples, and quality of life evaluations. Safety and adverse events related to treatment will also be monitored. Follow-up visits occur at baseline, 1 month, 3 months, 6 months, and 12 months to collect these measurements and monitor health status.

Fecal Microbiome Transplantation in Cirrhosis: Trial in Patients With Decompensated Cirrhosis