Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

Alcoholic Liver Disease Clinical Trial

Official title:

Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02335632
• Other study ID #: EPAH
• Status: Unknown status
• Phase: Phase 4
• First received: January 6, 2015
• Last updated: January 26, 2015
• Start date: December 2012
• Est. completion date: February 2015

Study information

• Verified date: January 2015
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 140
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• Hepatitis
• Hepatitis, Alcoholic
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Drug:
• Probiotics (Lacidofil®)
7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day)
• Placebo
For probiotics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver enzymes		7 days after probiotics
Secondary	LPS and pro-inflammatory cytokines		7 days after probiotics
Secondary	Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis		7 days after probiotics