Conditions: Hepatic Encephalopathy Cirrhosis
Keywords: Liver Failure Hepatic Insufficiency Liver Diseases Brain Diseases Rifaximin Cirrhosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 222
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.

Detailed description:

Arms:
arm 1: Participants will receive rifaximin 550 milligrams (mg) tablet orally twice daily (BID) for 24 weeks. arm 2: Participants will receive rifaximin 550 mg tablet orally BID with lactulose solution for 24 weeks. Lactulose dose will be self-titrated by the participant to produce 2 to 3 soft stools per day.

Interventions: intervention 1: Rifaximin intervention 2: Lactulose
Intervention descriptions: intervention 1: Rifaximin will be administered per the dose and schedule specified in the arms. intervention 2: Laculose will be administered per the schedule specified in the respective arm.

Protocol document: