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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alcohol, hepatitis, Placebo | Placebo Comparator | We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis |
|
| hepatitis, alcohol, probiotics | Active Comparator | We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hepatitis, alcohol, probiotics | Drug | 7 days of probiotics (1500 mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver Enzymes(ALT) | Blood analysis was performed using standard methodologies. | 7 days after probiotics |
| Measure | Description | Time Frame |
|---|---|---|
| Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines | 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. | 7 days after probiotics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki Tae Suk, PhD | Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital | Chuncheon | 200-704 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26302024 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcohol, Hepatitis, Placebo | Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation. |
| FG001 | Hepatitis, Alcohol, Probiotics | 7 days of probiotics (1500 mg/day) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol, Hepatitis, Placebo | Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation. |
| BG001 | Hepatitis, Alcohol, Probiotics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Liver Enzymes(ALT) | Blood analysis was performed using standard methodologies. | Posted | Mean | Standard Deviation | IU/L | 7 days after probiotics |
|
|
Serious and Other (Not Including Serious) Adverse Events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alcohol, Hepatitis, Placebo | Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ki Tae Suk | Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea | +82-33-240-5826 | ktsuk@hallym.ac.kr |
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| ID | Term |
|---|---|
| D008108 | Liver Diseases, Alcoholic |
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| D000431 | Ethanol |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| alcohol, hepatitis, Placebo | Drug | Placebos of the same shape and size were manufactured at Pharmaceutical Corporation. |
|
|
7 days of probiotics (1500 mg/day)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines | 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. | Posted | Mean | Standard Deviation | EU/mL | 7 days after probiotics |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Hepatitis, Alcohol, Probiotics | 7 days of probiotics (1500 mg/day) | 0 | 0 | 0 | 0 |
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| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D006505 | Hepatitis |
| D045424 |
| Complex Mixtures |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |