Clinical Trial: Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease

Brief 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.


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 September 2010 and April 2012, we 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.


Sponsor: Chuncheon Sacred Heart Hospital

Current Primary Outcome: Liver Enzymes(ALT) [ Time Frame: 7 days after probiotics ]

Blood analysis was performed using standard methodologies.


Original Primary Outcome: liver enzymes [ Time Frame: 7 days after probiotics ]

Current Secondary Outcome: Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines [ Time Frame: 7 days after probiotics ]

For the measurements of cytokines, homogenates of serum were processed with Human Tumor necrosis factor-alpha ELISA Kit and Human interleukin 1 beta ELISA Kit . For the measurement of LPS ELISA Kit was used. Assays were performed according to the manufacturer's instructions.


Original Secondary Outcome: LPS and pro-inflammatory cytokines [ Time Frame: 7 days after probiotics ]

Information By: Chuncheon Sacred Heart Hospital

Dates:
Date Received: December 27, 2011
Date Started: October 2010
Date Completion:
Last Updated: March 24, 2015
Last Verified: December 2014