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

March 24, 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 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.

Study Overview

Status

Completed

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 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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Chuncheon, Korea, Republic of, 200-704
        • Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Alcoholic Hepatitis

Exclusion Criteria:

  • Cancer
  • Viral Hepatitis, other Hepatitis

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: alcohol, hepatitis, Placebo
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
Drug: alcohol, hepatitis, Placebo
Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
Other Names:
  • Placebo
Active Comparator: hepatitis, alcohol, probiotics
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
Drug: hepatitis, alcohol, probiotics
7 days of probiotics (1500 mg/day)
Other Names:
  • LACTOWELL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver Enzymes(ALT)
Time Frame: 7 days after probiotics
Blood analysis was performed using standard methodologies.
7 days after probiotics

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines
Time Frame: 7 days after probiotics
For the measurements of cytokines, homogenates of serum were processed with Human Tumor necrosis factor-alpha ELISA Kit and Human interleukin 1 beta ELISA Kit . For the measurement of LPS ELISA Kit was used. Assays were performed according to the manufacturer's instructions.
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

Investigators

  • Principal Investigator: Ki Tae Suk, PhD, Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 27, 2011

First Submitted That Met QC Criteria

December 28, 2011

First Posted (Estimate)

December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPALD

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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