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Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

Primary Purpose

Alcoholic Liver Disease

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Probiotics (Lacidofil®)
Placebo
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Liver Disease focused on measuring Hepatitis, Probiotics, Lipopolysaccharides, Cytokines, Alcoholics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Probiotics

    Arm Description

    For Probiotics, 7 days

    Probiotics of 120 mg/day for 7days

    Outcomes

    Primary Outcome Measures

    liver enzymes

    Secondary Outcome Measures

    LPS and pro-inflammatory cytokines
    Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis

    Full Information

    First Posted
    January 6, 2015
    Last Updated
    January 26, 2015
    Sponsor
    Chuncheon Sacred Heart Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02335632
    Brief Title
    Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis
    Official Title
    Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2012 (undefined)
    Primary Completion Date
    February 2015 (Anticipated)
    Study Completion Date
    February 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chuncheon Sacred Heart Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcoholic Liver Disease
    Keywords
    Hepatitis, Probiotics, Lipopolysaccharides, Cytokines, Alcoholics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    For Probiotics, 7 days
    Arm Title
    Probiotics
    Arm Type
    Active Comparator
    Arm Description
    Probiotics of 120 mg/day for 7days
    Intervention Type
    Drug
    Intervention Name(s)
    Probiotics (Lacidofil®)
    Other Intervention Name(s)
    Lacidofil®
    Intervention Description
    7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    For probiotics
    Intervention Description
    For probiotics
    Primary Outcome Measure Information:
    Title
    liver enzymes
    Time Frame
    7 days after probiotics
    Secondary Outcome Measure Information:
    Title
    LPS and pro-inflammatory cytokines
    Time Frame
    7 days after probiotics
    Title
    Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis
    Time Frame
    7 days after probiotics

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

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    Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

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