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Background/Aims:
The investigators explored the therapeutic effects of probiotics in patients with AH.
Methods:
Between December 2012 and January 2015, 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, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis. 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 rhamnosus R0011/acidophilus R0052 (120 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis were checked at baseline and again after therapy.
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 December 2012 and January 2015, 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, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis. 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 rhamnosus R0011/acidophilus R0052 (120 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis were checked at baseline and again after therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | For Probiotics, 7 days |
|
| Probiotics | Active Comparator | Probiotics of 120 mg/day for 7days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics (Lacidofil®) | Drug | 7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| liver enzymes | 7 days after probiotics |
| Measure | Description | Time Frame |
|---|---|---|
| LPS and pro-inflammatory cytokines | 7 days after probiotics | |
| Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis | 7 days after probiotics |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 28, 2016 | |
| Reset | Feb 24, 2016 | |
| Release | Apr 27, 2016 | |
| Reset | Jun 2, 2016 | |
| Release | Jun 24, 2018 | |
| Reset | Jul 19, 2018 | |
| Release | Aug 10, 2020 | |
| Reset | Aug 20, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 28, 2016 | Feb 24, 2016 | |||
| Apr 27, 2016 |
| ID | Term |
|---|---|
| D008108 | Liver Diseases, Alcoholic |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Drug | For probiotics |
|
|
| Jun 2, 2016 |
| Jun 24, 2018 | Jul 19, 2018 |
| Aug 10, 2020 | Aug 20, 2020 |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D019602 |
| Food and Beverages |