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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease

Conditions
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Alcoholic Liver Disease

Intervention / Treatment
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* Drug: hepatitis, alcohol, probiotics
* Drug: alcohol, hepatitis, Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alcoholic Hepatitis Exclusion Criteria: Cancer Viral Hepatitis, other Hepatitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: alcohol, hepatitis, Placebo<br>We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis | Drug: alcohol, hepatitis, Placebo<br>* Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.<br>* Other names: Placebo;|
| Active Comparator: hepatitis, alcohol, probiotics<br>We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis | Drug: hepatitis, alcohol, probiotics<br>* 7 days of probiotics (1500 mg/day)<br>* Other names: LACTOWELL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Enzymes(ALT) | Blood analysis was performed using standard methodologies. | 7 days after probiotics | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days after probiotics | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis, alcohol