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

Sponsor
Chuncheon Sacred Heart Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01501162
Collaborator
(none)
130
Enrollment
1
Location
2
Arms
23
Duration (Months)
5.6
Patients Per Site Per Month

Study Details

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
  • 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
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 :
Oct 1, 2010
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

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 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Liver Enzymes(ALT) [7 days after probiotics]

      Blood analysis was performed using standard methodologies.

    Secondary Outcome Measures

    1. Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines [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

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Alcoholic Hepatitis
    Exclusion Criteria:

    • Cancer

    • Viral Hepatitis, other Hepatitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ki Tae Suk, doctor, assistant professor, Chuncheon Sacred Heart Hospital
    ClinicalTrials.gov Identifier:
    NCT01501162
    Other Study ID Numbers:
    • EPALD
    First Posted:
    Dec 29, 2011
    Last Update Posted:
    Apr 14, 2015
    Last Verified:
    Dec 1, 2014
    Keywords provided by Ki Tae Suk, doctor, assistant professor, Chuncheon Sacred Heart Hospital
    hepatitis, alcohol
    Additional relevant MeSH terms:
    Liver Diseases
    Liver Diseases, Alcoholic
    Ethanol

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Alcohol, Hepatitis, Placebo Hepatitis, Alcohol, Probiotics
    Arm/Group Description Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation. 7 days of probiotics (1500 mg/day)
    Period Title: Overall Study
    STARTED 65 65
    COMPLETED 57 60
    NOT COMPLETED 8 5

    Baseline Characteristics

    Arm/Group Title Alcohol, Hepatitis, Placebo Hepatitis, Alcohol, Probiotics Total
    Arm/Group Description Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation. 7 days of probiotics (1500 mg/day) Total of all reporting groups
    Overall Participants 57 60 117
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    57
    100%
    60
    100%
    117
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    53.8
    (12.4)
    52.7
    (9.4)
    52.7
    (11.3)
    Sex: Female, Male (Count of Participants)
    Female
    37
    64.9%
    38
    63.3%
    75
    64.1%
    Male
    20
    35.1%
    22
    36.7%
    42
    35.9%
    Region of Enrollment (participants) [Number]
    Korea, Republic of
    57
    100%
    60
    100%
    117
    100%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Alcohol, Hepatitis, Placebo Hepatitis, Alcohol, Probiotics
    Arm/Group Description Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation. 7 days of probiotics (1500 mg/day)
    Measure Participants 57 60
    Mean (Standard Deviation) [IU/L]
    66
    (136)
    48
    (49)
    2. Secondary Outcome
    Title Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines
    Description 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.
    Time Frame 7 days after probiotics

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Alcohol, Hepatitis, Placebo Hepatitis, Alcohol, Probiotics
    Arm/Group Description Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation. 7 days of probiotics (1500 mg/day)
    Measure Participants 57 60
    Mean (Standard Deviation) [EU/mL]
    2.1
    (2.7)
    1.7
    (1.6)

    Adverse Events

    Time Frame Serious and Other (Not Including Serious) Adverse Events were not collected/assessed
    Adverse Event Reporting Description
    Arm/Group Title Alcohol, Hepatitis, Placebo Hepatitis, Alcohol, Probiotics
    Arm/Group Description Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation. 7 days of probiotics (1500 mg/day)
    All Cause Mortality
    Alcohol, Hepatitis, Placebo Hepatitis, Alcohol, Probiotics
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Alcohol, Hepatitis, Placebo Hepatitis, Alcohol, Probiotics
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Alcohol, Hepatitis, Placebo Hepatitis, Alcohol, Probiotics
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Ki Tae Suk
    Organization Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
    Phone +82-33-240-5826
    Email ktsuk@hallym.ac.kr
    Responsible Party:
    Ki Tae Suk, doctor, assistant professor, Chuncheon Sacred Heart Hospital
    ClinicalTrials.gov Identifier:
    NCT01501162
    Other Study ID Numbers:
    • EPALD
    First Posted:
    Dec 29, 2011
    Last Update Posted:
    Apr 14, 2015
    Last Verified:
    Dec 1, 2014