Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease (EPALD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ki Tae Suk, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT01501162
First received: December 27, 2011
Last updated: March 24, 2015
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Alcoholic Liver Disease
Drug: hepatitis, alcohol, probiotics
Drug: alcohol, hepatitis, Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease

Resource links provided by NLM:


Further study details as provided by Chuncheon Sacred Heart Hospital:

Primary Outcome Measures:
  • Liver Enzymes(ALT) [ Time Frame: 7 days after probiotics ] [ Designated as safety issue: Yes ]
    Blood analysis was performed using standard methodologies.


Secondary Outcome Measures:
  • Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines [ Time Frame: 7 days after probiotics ] [ Designated as safety issue: Yes ]
    For the measurements of cytokines, homogenates of serum were processed with Human Tumor necrosis factor-alpha ELISA Kit and Human interleukin 1 beta ELISA Kit . For the measurement of LPS ELISA Kit was used. Assays were performed according to the manufacturer's instructions.


Enrollment: 130
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: alcohol, hepatitis, Placebo
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
Drug: alcohol, hepatitis, Placebo
Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
Other Name: Placebo
Active Comparator: hepatitis, alcohol, probiotics
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
Drug: hepatitis, alcohol, probiotics
7 days of probiotics (1500 mg/day)
Other Name: LACTOWELL

Detailed 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 September 2010 and April 2012, we 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alcoholic Hepatitis

Exclusion Criteria:

  • Cancer
  • Viral Hepatitis, other Hepatitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501162

Locations
Korea, Republic of
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Korea, Republic of, 200-704
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Investigators
Principal Investigator: Ki Tae Suk, PhD Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
  More Information

No publications provided

Responsible Party: Ki Tae Suk, doctor, assistant professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01501162     History of Changes
Other Study ID Numbers: EPALD
Study First Received: December 27, 2011
Results First Received: December 31, 2014
Last Updated: March 24, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chuncheon Sacred Heart Hospital:
hepatitis, alcohol

Additional relevant MeSH terms:
Liver Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Digestive System Diseases
Substance-Related Disorders
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015