Branch Chain Amino Acids vs Rifaximin for Secondary Prevention of Hepatic Encephalopathy in Cirrhosis: Double-blind Placebo-controlled Multicenter Randomized Trial

What this Trial Is About

Researchers are evaluating the use of oral branched-chain amino acids (BCAA) versus rifaximin as secondary prevention treatments in patients with cirrhosis who have recovered from an episode of overt hepatic encephalopathy (HE). This phase 4, double-blind, placebo-controlled, randomized trial aims to determine which treatment better prevents recurrence of HE and improves cognitive function, mental health, and quality of life. The study addresses important challenges in Indian patients who often experience sarcopenia and gut dysbiosis, conditions that may worsen HE and its recurrence. The study compares two treatment groups over 12 weeks: one receiving oral BCAA once daily plus lactulose and a rifaximin placebo, and the other receiving rifaximin twice daily plus lactulose and a BCAA placebo. Both groups will be monitored for recurrence of HE episodes and changes in neurocognitive function. The double-dummy design helps reduce bias by ensuring all participants take similar appearing treatments. The trial also includes follow-up assessments of muscle health, ammonia levels, and psychiatric status. Participants will undergo computerized cognitive tests and psychiatric assessments at enrollment, 30 days, and 90 days. Health-related quality of life will be measured using the SF-36 questionnaire. Researchers will monitor ammonia and muscle health changes across the study period. The primary outcome is the number of overt HE breakthrough events within 24 weeks. Safety and efficacy data will be collected during the trial, which runs through August 2027. Participant involvement includes regular drug dosing, questionnaires, and clinical evaluations to assess treatment impact and side effects.

BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE