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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01501162
Recruitment Status : Completed
First Posted : December 29, 2011
Results First Posted : January 27, 2015
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Alcoholic Liver Disease Drug: hepatitis, alcohol, probiotics Drug: alcohol, hepatitis, Placebo Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Study Start Date : October 2010
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: LACTOWELL


Outcome Measures

Primary Outcome Measures :
  1. Liver Enzymes(ALT) [ Time Frame: 7 days after probiotics ]
    Blood analysis was performed using standard methodologies.


Secondary Outcome Measures :
  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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alcoholic Hepatitis

Exclusion Criteria:

  • Cancer
  • Viral Hepatitis, other Hepatitis
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501162


Locations
Korea, Republic of
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Korea, Republic of, 200-704
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Investigators
Principal Investigator: Ki Tae Suk, PhD Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ki Tae Suk, doctor, assistant professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01501162     History of Changes
Other Study ID Numbers: EPALD
First Posted: December 29, 2011    Key Record Dates
Results First Posted: January 27, 2015
Last Update Posted: April 14, 2015
Last Verified: December 2014

Keywords provided by Ki Tae Suk, Chuncheon Sacred Heart Hospital:
hepatitis, alcohol

Additional relevant MeSH terms:
Liver Diseases
Liver Diseases, Alcoholic
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs