Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease (EPALD)

Chuncheon Sacred Heart Hospital

Status and phase: Completed; Phase 4

Conditions: Alcoholic Liver Disease

Treatments: Drug: hepatitis, alcohol, probiotics; Drug: alcohol, hepatitis, Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01501162

EPALD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Alcoholic Hepatitis

Exclusion criteria

• Cancer
• Viral Hepatitis, other Hepatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups, including a placebo group

alcohol, hepatitis, Placebo

Placebo Comparator group

Description:

We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis

Treatment:

Drug: alcohol, hepatitis, Placebo

hepatitis, alcohol, probiotics

Active Comparator group

Description:

We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis

Treatment:

Drug: hepatitis, alcohol, probiotics