Detalle de: LIVERGUT. Fecal microbiome transplantation in cirrhosis. Randomized double-blind, placebo-controlled trials in patients with compensated and decompensated cirrhosis

Cirrhosis is a very prevalent disease with high mortality. The initial asymptomatic phase (compensated cirrhosis) is followed by a symptomatic phase (decompensated cirrhosis) characterized by severe complications that cause frequent hospitalizations, deterioration of quality of life and death of the patient in the absence of transplantation. Cirrhosis represents a major economic burden on health systems and has received less attention than other chronic diseases. conditions, in part due to the stigmatization of the disease. There is an unmet need for effective therapies to prevent complications of cirrhosis. Several lines of evidence indicate that alterations in the gut microbiome that cause impairment in the gut-liver axis play a pathogenic role in the progression of cirrhosis and correlate with prognosis. Studies in a small number of patients have shown that fecal microbiome transplantation (FMT) from healthy donors to patients with cirrhosis restores the gut microbiome and improves one of its complications, hepatic encephalopathy. However, it is not known whether FMT has favorable effects on the prevention of other complications of cirrhosis and progressive disease. The aim of this project ("LIVERGUT") is to evaluate the effects of FMT in cirrhosis. Two hundred and forty-four patients will be included in two randomized, double-blind, placebo-controlled Phase III trials. The primary endpoints will be reduction in portal hypertension, as assessed by pressure gradient in compensated patients, and reduction in a combined endpoint of complications of cirrhosis in decompensated patients.