Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

January 26, 2015 updated by: Ki Tae Suk, Chuncheon Sacred Heart Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
For Probiotics, 7 days
Drug: Placebo
For probiotics
Other Names:
  • For probiotics
Active Comparator: Probiotics
Probiotics of 120 mg/day for 7days
Drug: Probiotics (Lacidofil®)
7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day)
Other Names:
  • Lacidofil®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
liver enzymes
Time Frame: 7 days after probiotics
7 days after probiotics

Secondary Outcome Measures

Outcome Measure
Time Frame
LPS and pro-inflammatory cytokines
Time Frame: 7 days after probiotics
7 days after probiotics
Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis
Time Frame: 7 days after probiotics
7 days after probiotics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Estimate)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPAH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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