Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

Phase 4

• Conditions: Alcoholic Liver Disease
• Interventions: Drug: Placebo; Drug: Probiotics (Lacidofil®)

• Registration Number: NCT02335632
• Lead Sponsor: Chuncheon Sacred Heart Hospital

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 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.

Study Timeline

• Study Start: 2012-12
• Status Verified: 2015-01
• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-12
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-28
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	For Probiotics, 7 days
Probiotics	Probiotics (Lacidofil®)	Probiotics of 120 mg/day for 7days

Primary Outcome Measures

Name	Time	Method
liver enzymes	7 days after probiotics

Secondary Outcome Measures

Name	Time	Method
LPS and pro-inflammatory cytokines	7 days after probiotics
Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis	7 days after probiotics