Phase 4
N=130
Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Alcoholic Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT01501162 ↗Enrolled (actual)
130
Serious AEs
—
Results posted
Jan 2015
Primary outcome: Primary: Liver Enzymes(ALT) — 66; 48 IU/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- hepatitis, alcohol, probiotics (Drug); alcohol, hepatitis, Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chuncheon Sacred Heart Hospital
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Liver Enzymes(ALT) |
66; 48 | — |
| SECONDARY Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines |
2.1; 1.7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Alcoholic Hepatitis
Exclusion Criteria
- Cancer
- Viral Hepatitis, other Hepatitis
Data sourced from ClinicalTrials.gov (NCT01501162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.