Study design and participants
liver biopsy-proven alcohol-related liver disease, alcohol-related liver fibrosis
SECONDARY, LIVER FIBROSIS
GALA-RIF was an investigator-initiated, randomised, double-blind, placebo-controlled, single-centre, phase 2 trial investigating the efficacy of rifaximin-α in patients with liver biopsy-proven alcohol-related liver disease. All participants were recruited at the Department of Gastroenterology and Hepatology at Odense University Hospital (Odense, Denmark).The regional ethics committee approved the study (S-20140078) and all patients provided written informed consent. The trial was conducted according to the principles of the International Conference on Harmonization Good Clinical Practice guidelines and externally monitored by the Good Clinical Practice Unit at Odense University Hospital. A full version of the protocol is available in the We identified potential participants from a clinical study that screened for alcohol-related liver fibrosis in individuals from primary and secondary care who had previous or current alcohol overuse defined as 24 g per day or more for at least 1 year in women, and 36 g or more per day for at least 1 year for men.In the protocol, patients were required to have an Ishak score of 1–4 for liver fibrosis on biopsies.