Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease (EPALD)
Primary Purpose
Alcoholic Liver Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
hepatitis, alcohol, probiotics
alcohol, hepatitis, Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholic Liver Disease focused on measuring hepatitis, alcohol
Eligibility Criteria
Inclusion Criteria:
- Alcoholic Hepatitis
Exclusion Criteria:
- Cancer
- Viral Hepatitis, other Hepatitis
Sites / Locations
- Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
alcohol, hepatitis, Placebo
hepatitis, alcohol, probiotics
Arm Description
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
Outcomes
Primary Outcome Measures
Liver Enzymes(ALT)
Blood analysis was performed using standard methodologies.
Secondary Outcome Measures
Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines
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.
Full Information
NCT ID
NCT01501162
First Posted
December 27, 2011
Last Updated
March 24, 2015
Sponsor
Chuncheon Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01501162
Brief Title
Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Acronym
EPALD
Official Title
Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Liver Disease
Keywords
hepatitis, alcohol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
alcohol, hepatitis, Placebo
Arm Type
Placebo Comparator
Arm Description
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
Arm Title
hepatitis, alcohol, probiotics
Arm Type
Active Comparator
Arm Description
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
Intervention Type
Drug
Intervention Name(s)
hepatitis, alcohol, probiotics
Other Intervention Name(s)
LACTOWELL
Intervention Description
7 days of probiotics (1500 mg/day)
Intervention Type
Drug
Intervention Name(s)
alcohol, hepatitis, Placebo
Other Intervention Name(s)
Placebo
Intervention Description
Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
Primary Outcome Measure Information:
Title
Liver Enzymes(ALT)
Description
Blood analysis was performed using standard methodologies.
Time Frame
7 days after probiotics
Secondary Outcome Measure Information:
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
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
Exclusion Criteria:
Cancer
Viral Hepatitis, other Hepatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Tae Suk, PhD
Organizational Affiliation
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
City
Chuncheon
ZIP/Postal Code
200-704
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
26302024
Citation
Han SH, Suk KT, Kim DJ, Kim MY, Baik SK, Kim YD, Cheon GJ, Choi DH, Ham YL, Shin DH, Kim EJ. Effects of probiotics (cultured Lactobacillus subtilis/Streptococcus faecium) in the treatment of alcoholic hepatitis: randomized-controlled multicenter study. Eur J Gastroenterol Hepatol. 2015 Nov;27(11):1300-6. doi: 10.1097/MEG.0000000000000458.
Results Reference
derived
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Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
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