This is a phase III, multicenter, double-blind, placebo-controlled, randomized clinical trial to evaluate the safety and efficacy of Fecal Microbiota Transplantation (FMT) from healthy subjects to patients with decompensated cirrhosis.
Age ≥ 18 years old.
Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any etiology may be included except from patients with cirrhosis due to autoimmune hepatitis, and patients with cirrhosis due to cholestatic liver disease can only be included in the study if they present clinical decompensation of cirrhosis (i.e. ascites).
Child-Pugh B or C patients (7- up to 12 points).
Women of child-bearing potential* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence** (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
Previous history of gastrointestinal surgery or colorectal cancer.
Patients with previous history of intestinal obstruction or those who are at increased risk of this complication.
Active Clostridium Difficile infection.
Patients on treatment with non-selective beta-blockers for <3 month or without stable doses.
Parallel
Fecal Microbiome Transplantation (FMT)
DrugTwo doses: First dose: 24 capsules of FMT at baseline. Second dose: 24 capsules of FMT at 3 months.
FMT Placebo
Other interventionTwo doses: First dose: 24 capsules of FMT placebo at baseline. Second dose: 24 capsules of FMT placebo at 3 months.
Efficacy of treatment in halting the progression of decompensated cirrhosis.
Assessed by time to first decompensation event (acute kidney injury (AKI), ascites, bacterial infection, gastrointestinal bleeding, HE).
Time to transplant-free survival
Assessed by transplant-free survival
Mortality rates
Assessed by mortality rates
Rate of patients developing/ worsening individual complications of cirrhosis.
Assessed by ascites, acute kidney injury, bacterial infections, gastrointestinal bleeding and hepatic encephalopathy.
Frequency of hospital admissions due to complications of cirrhosis.
Assessed by hospital admissions due to complications of cirrhosis.
Click on the lead sponsor to view all of their trials.
