drugset / Trial / NCT01110447

Secondary Prophylaxis of Hepatic Encephalopathy With a Probiotic Preparation

NCT01110447 ↗

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The aim of the proposed project is to study the effects of a probiotic preparation (VSL#3®) for the prevention of recurrence of HE (Hepatic encephalopathy) in patients after the recovery of an episode of overt HE (secondary prophylaxis)

Timeline

Start
2010-04
Primary completion
2013-03
Completion
2013-03

Outcome

Missed primary endpoint

paper 34.8% in the probiotic group vs 51.6% in the placebo group; hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.38-1.11; P = .12. PMID 25450083 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject VSL#3 Other / unclassified 9e+11 cells —