Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

• Status: Unknown status
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chuncheon Sacred Heart Hospital

Criteria

Inclusion Criteria:

• Alcoholic hepatitis (AST/ALT >2 & elevated AST (ALT) level

• Alcohol >60 g/day (M), >40 g/day (F) during 7 days before screening

• Last drinks: within 48 hours prior to admission)

Exclusion Criteria:

• viral hepatitis,

• autoimmune hepatitis,

• pancreatitis,

• hemochromatosis,

• Wilson's disease,

• Drug-Induced Liver Injury,

• cancer,

• infection need for antibiotics,

• severe AH, or

• obesity (BMI >30 kg/m2)