The Effect of Probiotics (VSL) on Portal Hypertension

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will address the hypothesis that portal hypertension is mediated in part by bacterial or endotoxin translocation and the production of inflammatory mediators (tumor necrosis factor-α (TNFα), etc.). The investigators hypothesize that food supplementation with the probiotic product VSL#3 in patients with Child Pugh B/C cirrhosis will have a beneficial effect on in portal pressure (as measured by the HVPG) by reducing inflammatory mediators and improving systemic and splanchnic hemodynamics.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alberta

Criteria

Inclusion Criteria:

• Age 18-80

• Cirrhosis

• Childs-Pugh Class B/C

Exclusion Criteria:

• Bacterial infection

• Grade 3-4 hepatic encephalopathy

• GI bleeding in the past 2 weeks

• Hepatocellular carcinoma beyond the Milan criteria

• Transjugular intrahepatic portosystemic shunt (TIPS), surgical shunt

• Portal vein thrombosis

• Antibiotics in the past 2 weeks

• Myocardial infarction, stroke or life-threatening arrhythmia within the last 6 months

• Active alcohol or illicit drug use

• Failure to consent to the study