Clinical trial NCT02335632: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alcoholic Liver Disease
Keywords: Hepatitis
Probiotics
Lipopolysaccharides
Cytokines
Alcoholics
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: liver enzymes
timeFrame: 7 days after probiotics
Secondary outcomes:
measure: LPS and pro-inflammatory cytokines
timeFrame: 7 days after probiotics
measure: Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis
timeFrame: 7 days after probiotics
Other outcomes:
Locations:
Study officials:
References: