Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Eradication rate of Helicobacter pylori
研究概览
简要总结
The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.
详细描述
The success rate of currently recommended triple therapy with a proton pump inhibitor (PPI) plus amoxicillin and clarithromycin has fallen into the unacceptable range. The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment, while ten day triple therapy is used as control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcers
排除标准
- •patients less than 18 years old, with history of H. pylori infection treatment, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks, or allergy to any one of the given medication in the regimens.
研究组 & 干预措施
10 day Quadruple Therapy
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
干预措施: Esomeprazole (Drug)
10 day Quadruple Therapy
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
干预措施: Amoxicillin (Drug)
10 day Quadruple Therapy
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
干预措施: Clarithromycin (Drug)
10 day Quadruple Therapy
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
干预措施: Bismuth Potassium Citrate (Drug)
10 day Triple therapy
Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days
干预措施: Esomeprazole (Drug)
10 day Triple therapy
Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days
干预措施: Amoxicillin (Drug)
10 day Triple therapy
Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days
干预措施: Clarithromycin (Drug)
14 day quadruple therapy
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
干预措施: Esomeprazole (Drug)
14 day quadruple therapy
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
干预措施: Amoxicillin (Drug)
14 day quadruple therapy
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
干预措施: Clarithromycin (Drug)
14 day quadruple therapy
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
干预措施: Bismuth Potassium Citrate (Drug)
14 day quadruple therapy
Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
干预措施: long duration (14 day) (Other)
结局指标
主要结局
Eradication rate of Helicobacter pylori
时间窗: 2 months
To calculate and compare the efficacy of 10 day and 14 day triple therapies with and without bismuth,to examine whether long duration and addition of bismuth affects the eradication.
次要结局
未报告次要终点
研究者
Dr. HONG LU
Professor of GI Division
Shanghai Jiao Tong University School of Medicine