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

Phase 4

Completed

Interventions: Drug: hepatitis, alcohol, probiotics
Drug: alcohol, hepatitis, Placebo

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 Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
hepatitis, alcohol, probiotics	hepatitis, alcohol, probiotics	We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
alcohol, hepatitis, Placebo	alcohol, hepatitis, Placebo	We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis

Primary Outcome Measures

Name	Time	Method
Liver Enzymes(ALT)	7 days after probiotics	Blood analysis was performed using standard methodologies.

Secondary Outcome Measures

Name	Time	Method
Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines	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.