drugset / Trial / NCT01501162

Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease

NCT01501162

Phase 4 Completed 130 enrolled Chuncheon Sacred Heart Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Background/Aims: The investigators explored the therapeutic effects of probiotics in patients with AH. Methods: Between September 2010 and April 2012, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline and again after therapy.

Timeline

Start
2010-10
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Probiotics Other / unclassified 1500 mg Oral