Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

Chuncheon Sacred Heart Hospital

Status and phase: Unknown; Phase 4

Conditions: Alcoholic Liver Disease

Treatments: Drug: Placebo; Drug: Probiotics (Lacidofil®)

Study type: Interventional

Funder types: Other

Identifiers

NCT02335632

EPAH

Details and patient eligibility

About

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.

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 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

For Probiotics, 7 days

Treatment:

Drug: Placebo

Probiotics

Active Comparator group

Description:

Probiotics of 120 mg/day for 7days

Treatment:

Drug: Probiotics (Lacidofil®)