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
About this trial
This is an interventional treatment trial for Alcoholic Liver Disease focused on measuring Hepatitis, Probiotics, Lipopolysaccharides, Cytokines, Alcoholics
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)
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
NCT ID
NCT02335632
First Posted
January 6, 2015
Last Updated
January 26, 2015
Sponsor
Chuncheon Sacred Heart Hospital
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
Learn more about this trial
Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis
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