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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Chuncheon Sacred Heart Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ki Tae Suk, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT01501162
First received: December 27, 2011
Last updated: December 28, 2011
Last verified: December 2011
  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 cultured lactobacillus subtilis/streptococcus faecium (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: LACTOWELL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group 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 [ Time Frame: 7 days after probiotics ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • LPS and pro-inflammatory cytokines [ Time Frame: 7 days after probiotics ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: alcohol, hepatitis, probiotics
We explored the therapeutic effects of probiotics in patients with AH
Drug: LACTOWELL
7 days of cultured lactobacillus subtilis/streptococcus faecium (1500 mg/day)
Other Name: cultured lactobacillus subtilis/streptococcus faecium
Placebo Comparator: hepatitis, alcohol, probiotics
We explored the therapeutic effects of probiotics in patients with AH
Drug: LACTOWELL
7 days of cultured lactobacillus subtilis/streptococcus faecium (1500 mg/day)
Other Name: cultured lactobacillus subtilis/streptococcus faecium

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 cultured lactobacillus subtilis/streptococcus faecium (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

Contacts
Contact: Ki Tae Suk, M.D., Ph.D. ktsuk@hallym.ac.kr

Locations
Korea, Republic of
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital Enrolling by invitation
Chuncheon, Korea, Republic of, 200-704
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital Recruiting
Chuncheon, Korea, Republic of, 200-704
Contact: Ki Tae Suk, M.D., Ph.D.       ktsuk@hallym.ac.kr   
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
Last Updated: December 28, 2011
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
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 20, 2014