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Completed

NCT Number: NCT01501162

Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease

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.

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Key information

Conditions

Alcoholic Liver Disease Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Hepatitis Hepatitis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, 200-704, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Alcoholic Hepatitis

Exclusion criteria

  • Cancer
  • Viral Hepatitis, other Hepatitis

Treatment and study plan

hepatitis, alcohol, probiotics

Drug

7 days of probiotics (1500 mg/day)

Other names: LACTOWELL

alcohol, hepatitis, Placebo

Drug

Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.

Other names: Placebo

Primary outcomes

  1. Liver Enzymes(ALT)

    Time frame: 7 days after probiotics

    Blood analysis was performed using standard methodologies.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Registry information

Acronym: EPALD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 29, 2011
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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