Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
NCT ID: NCT01501162
Last Updated: 2015-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
130 participants
INTERVENTIONAL
2010-10-31
2012-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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alcohol, hepatitis, Placebo
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
alcohol, hepatitis, Placebo
Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
hepatitis, alcohol, probiotics
We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis
hepatitis, alcohol, probiotics
7 days of probiotics (1500 mg/day)
Interventions
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hepatitis, alcohol, probiotics
7 days of probiotics (1500 mg/day)
alcohol, hepatitis, Placebo
Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Viral Hepatitis, other Hepatitis
18 Years
80 Years
ALL
No
Sponsors
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Chuncheon Sacred Heart Hospital
OTHER
Responsible Party
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Ki Tae Suk
doctor, assistant professor
Principal Investigators
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Ki Tae Suk, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Locations
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Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, , South Korea
Countries
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References
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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.
Other Identifiers
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EPALD
Identifier Type: -
Identifier Source: org_study_id
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