CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 130 enrolled
Drug / intervention
hepatitis, alcohol, probiotics +1 moredrug
Likely dose
hepatitis, alcohol, probiotics 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01501162
NCT01501162Phase 4Completed

Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease

Chuncheon Sacred Heart Hospital·interventional·Posted Dec 29, 2011·Updated Apr 14, 2015

In Brief

A Phase 4 clinical trial evaluating hepatitis, alcohol, probiotics and alcohol, hepatitis, Placebo for Alcoholic Liver Disease. Completed, enrolled 130 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 29, 2011
Enrollment StartOct 1, 2010
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.5 years ago

Interventions

hepatitis, alcohol, probioticsdrug

7 days of probiotics (1500 mg/day)

alcohol, hepatitis, Placebodrug

Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.