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

NCT01501162 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2015-04-14

Study results available
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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.

Conditions

Interventions

DRUG

hepatitis, alcohol, probiotics

7 days of probiotics (1500 mg/day)

DRUG

alcohol, hepatitis, Placebo

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

Sponsors & Collaborators

  • Chuncheon Sacred Heart Hospital

    lead OTHER

Principal Investigators

  • Ki Tae Suk, PhD · Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01501162 on ClinicalTrials.gov