Overview

This trial is active, not recruiting.

Condition alcoholic liver disease
Treatments probiotics (lacidofil®), placebo
Phase phase 4
Sponsor Chuncheon Sacred Heart Hospital
Start date December 2012
End date February 2015
Trial size 140 participants
Trial identifier NCT02335632, EPAH

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
For Probiotics, 7 days
placebo For probiotics
For probiotics
(Active Comparator)
Probiotics of 120 mg/day for 7days
probiotics (lacidofil®) Lacidofil®
7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day)

Primary Outcomes

Measure
liver enzymes
time frame: 7 days after probiotics

Secondary Outcomes

Measure
LPS and pro-inflammatory cytokines
time frame: 7 days after probiotics
Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis
time frame: 7 days after probiotics

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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)

Additional Information

Official title Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Chuncheon Sacred Heart Hospital.