Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 140
- 主要终点
- liver enzymes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alcoholic hepatitis (AST/ALT >2 & elevated AST (ALT) level
- •Alcohol >60 g/day (M), >40 g/day (F) during 7 days before screening
- •Last drinks: within 48 hours prior to admission)
排除标准
- •viral hepatitis,
- •autoimmune hepatitis,
- •pancreatitis,
- •hemochromatosis,
- •Wilson's disease,
- •Drug-Induced Liver Injury,
- •infection need for antibiotics,
- •severe AH, or
- •obesity (BMI >30 kg/m2)
研究组 & 干预措施
Placebo
For Probiotics, 7 days
干预措施: Placebo (Drug)
Probiotics
Probiotics of 120 mg/day for 7days
干预措施: Probiotics (Lacidofil®) (Drug)
结局指标
主要结局
liver enzymes
时间窗: 7 days after probiotics
次要结局
- LPS and pro-inflammatory cytokines(7 days after probiotics)
- Stool culture and stool Polymerase chain reaction denaturing gradient gel electrophoresis(7 days after probiotics)
研究者
Ki Tae Suk
Department of Internal Medicine
Chuncheon Sacred Heart Hospital