Clinical Trial: Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis
Brief 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.
Detailed Summary:
Background/Aims: Alcoholic hepatitis (AH) is one of the leading causes of liver diseases. Gut-derived microbial lipopolysaccharide (LPS) has been known as a central role in the pathogenesis of AH. Some animal studies suggested an emerging role of probiotics in restoration of the bowel flora and improving liver enzymes. We 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.
Sponsor: Chuncheon Sacred Heart Hospital
Current Primary Outcome: liver enzymes [ Time Frame: 7 days after probiotics ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- LPS and pro-inflammatory cytokines [ Time Frame: 7 days after probiotics ]
- Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis [ Time Frame: 7 days after probiotics ]
Original Secondary Outcome: Same as current
Information By: Chuncheon Sacred Heart Hospital
Dates:
Date Received: January 6, 2015
Date Started: December 2012
Date Completion: February 2015
Last Updated: January 26, 2015
Last Verified: January 2015
