Bacterial translocation and amelioration of liver cell damage in response to treatment with propranolol, with or without rifaximin, in patients with cirrhosis and portal hypertensio

Phase 2

• Conditions: Cirrhosis and portal hypertension; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612001026819
• Lead Sponsor: Professor Stephen Riordan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Cirrhosis
Portal hypertension

Exclusion Criteria

Propranolol treatment in the previous three months
Antibiotic treatment within the previous three months
Hepatocellular carcinoma
Inability to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Portal venous pressure, as assessed by direct measurement of the hepatic venous pressure gradient[Baseline, after 28 days of propranolol and, when reduction in portal venous hypertension is inadequate, after 28 days of combined propranolol and rifaximin. <br><br>Patients intolerant of or with contraindications to propranolol will be studied at baseline and after 28 days of rifaximin monotherapy.]

Secondary Outcome Measures

Name	Time	Method
Bacterial translocation/liver cell function, as assessmed by analysis of peripheral blood for bacterial DNA, innate immune activity and standard liver function tests.[Baseline, after 28 days of propranolol and, when reduction in portal venous hypertension is inadequate, after 28 days of combined propranolol and rifaximin. <br><br>Patients intolerant of or with contraindications to propranolol will be studied at baseline and after 28 days of rifaximin monotherapy.]