Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alcoholic Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

For Probiotics, 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

For probiotics

Probiotics

Probiotics of 120 mg/day for 7days

Group Type ACTIVE_COMPARATOR

Probiotics (Lacidofil®)

Intervention Type DRUG

7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day)

Interventions

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Probiotics (Lacidofil®)

7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day)

Intervention Type DRUG

Placebo

For probiotics

Intervention Type DRUG

Other Intervention Names

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Lacidofil® For probiotics

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No