Alcoholic Liver Disease
Conditions
Keywords
Hepatitis, Probiotics, Lipopolysaccharides, Cytokines, Alcoholics
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.
Interventions
DRUGProbiotics (Lacidofil®)
7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day)
DRUGPlacebo
For probiotics
Sponsors
Chuncheon Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| liver enzymes | 7 days after probiotics |
Secondary
| Measure | Time frame |
|---|---|
| LPS and pro-inflammatory cytokines | 7 days after probiotics |
| Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis | 7 days after probiotics |
Outcome results
None listed