NCT01501162|CompletedPhase 4ResultsDMC
Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
EPALD
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Sponsor study identifier
interventional
130
1 country
1
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2012
Actual (reported)Study Completion
September 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
December 27, 2011
Actual (reported)December 29, 2011
Actual (reported)September 2012
Actual (reported)September 2012
Actual (reported)January 27, 2015
Actual (reported)Liver Enzymes(ALT)
Blood analysis was performed using standard methodologies.
7 days after probiotics
Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines
7 days after probiotics
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
7 days of probiotics (1500 mg/day)
Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, 200-704, South Korea
Han SH, Suk KT, Kim DJ, Kim MY, Baik SK, Kim YD, Cheon GJ, Choi DH, Ham YL, Shin DH, Kim EJ. Effects of probiotics (cultured Lactobacillus subtilis/Streptococcus faecium) in the treatment of alcoholic hepatitis: randomized-controlled multicenter study. Eur J Gastroenterol Hepatol. 2015 Nov;27(11):1300-6. doi: 10.1097/MEG.0000000000000458.
Ki Tae Suk, PhD
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
130 participants (actual enrollment reported by the registry).
First Submitted
December 27, 2011
First Posted
December 29, 2011
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease
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Primary Completion
September 2012
Actual (reported)Study Completion
September 2012
Actual (reported)Last Updated
April 14, 2015
Results First Posted
January 27, 2015
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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