Clinical Trial of Probiotics in Preventing Complication Related to Portal Hypertension in Cirrhotic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Admission Due to Complications Related to Portal Hypertension
研究概览
简要总结
Recent studies indicate that probiotics can stimulate intestinal immunity and tighten the junctions of epithelial cells. By these ways, probiotics can reduce bacterial translocation; hence, they can ameliorate systemic inflammatory status. Because cirrhotic patients with portal hypertension often suffer from infections from intestinal flora, the investigators speculate that probiotics will be beneficial to those patients.
详细描述
The investigators will recruit appropriate patients, 120 in number, randomly allocate into control and experimental arms. They will be given GK#10 or placebo for 8 weeks. Clinical parameters, such as liver function, renal function, and general conditions will be evaluated at specific time points, week 0, 5, 9, and 13 weeks. Primary outcome measurement will be survival and major complications analysis, and secondary outcome measurement will be liver function evaluation.
The investigators anticipate providing our sponsor with useful results about GK#10. The investigators will make clear the impacts from individual strains, the investigators will validate our speculation that probiotics do no harm to cirrhotic patients with portal hypertension, even be beneficial to them. If the investigators can validate the anticipation, patients can enjoy benefits from our study, and the probiotics may have the potential to sell to the patients in the world.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with history of complications related to liver cirrhosis, including hepatic encephalopathy, variceal bleeding, and spontaneous bacterial peritonitis
- •Patients with evidences of portal hypertension, such as hepatosplenomegaly, thrombocytopenia (< 100,000/ml)
排除标准
- •Active infection
- •Dialysis patients, myocardial infarction, life-threatening cardiac arrythmia and stroke
- •Hepatocellular carcinoma with life expectancy < 6 months
- •Portal vein thrombosis
- •in hepatic encephalopathy or liver function ALT > 3 x UNL, T-bilirubin > 4.0 mg/dL
- •GI tract bleeding in recent 1 weeks
- •Drug abuser
- •No informed consent
研究组 & 干预措施
GK#10
GK#10 1 pk tid for 8 weeks
干预措施: GK#10 (Dietary Supplement)
Placebo
Placebo 1 pack tid for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Admission Due to Complications Related to Portal Hypertension
时间窗: 8 weeks
次要结局
- Liver Function Evaluation(8 weeks)
研究者
Po-Lin Chen, MD
Doctor
National Cheng-Kung University Hospital