drugset / Trial / NCT02335632

Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

NCT02335632 ↗

Phase 4 Unknown 140 enrolled Chuncheon Sacred Heart Hospital
RandomizedSingle-groupQuadruple-blindTreatment

Summary

Background/Aims: The investigators explored the therapeutic effects of probiotics in patients with AH. Methods: Between December 2012 and January 2015, 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, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis. 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 cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis were checked at baseline and again after therapy.

Timeline

Start
2012-12
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lacidofil Other / unclassified 120 mg —