Alcoholic Liver Disease
Conditions
Keywords
hepatitis, alcohol
Brief summary
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.
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 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.
Interventions
DRUGhepatitis, alcohol, probiotics
7 days of probiotics (1500 mg/day)
DRUGalcohol, hepatitis, Placebo
Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
Sponsors
Chuncheon Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Alcoholic Hepatitis
Exclusion criteria
* Cancer * Viral Hepatitis, other Hepatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Enzymes(ALT) | 7 days after probiotics | Blood analysis was performed using standard methodologies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines | 7 days after probiotics | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alcohol, Hepatitis, Placebo Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation. | 57 |
| Hepatitis, Alcohol, Probiotics 7 days of probiotics (1500 mg/day) | 60 |
| Total | 117 |
Baseline characteristics
| Characteristic | Hepatitis, Alcohol, Probiotics | Alcohol, Hepatitis, Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 57 Participants | 117 Participants |
| Age, Continuous | 52.7 years STANDARD_DEVIATION 9.4 | 53.8 years STANDARD_DEVIATION 12.4 | 52.7 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment Korea, Republic of | 60 participants | 57 participants | 117 participants |
| Sex: Female, Male Female | 38 Participants | 37 Participants | 75 Participants |
| Sex: Female, Male Male | 22 Participants | 20 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Liver Enzymes(ALT)
Blood analysis was performed using standard methodologies.
Time frame: 7 days after probiotics
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol, Hepatitis, Placebo | Liver Enzymes(ALT) | 66 IU/L | Standard Deviation 136 |
| Hepatitis, Alcohol, Probiotics | Liver Enzymes(ALT) | 48 IU/L | Standard Deviation 49 |
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.
Time frame: 7 days after probiotics
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohol, Hepatitis, Placebo | Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines | 2.1 EU/mL | Standard Deviation 2.7 |
| Hepatitis, Alcohol, Probiotics | Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines | 1.7 EU/mL | Standard Deviation 1.6 |