Helicobacter Pylori Eradication and Follow-up in Zhongshan Hospital
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4,447
- 试验地点
- 1
- 主要终点
- Eradication rate of Helicobacter pylori
研究概览
简要总结
This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
- •18-75 years old on the day of signing the ICF.
- •Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
排除标准
- •Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
- •Subjects or guardians refused to participate in the trial.
- •Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
- •Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
- •Pregnant or lactating women.
- •Active peptic ulcer.
- •allergic to drugs used in the trial.
- •any other circumstances that are not suitable for recruitment.
研究组 & 干预措施
RBCL
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days
干预措施: Rabeprazole (Drug)
RBCL
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days
干预措施: Bismuth potassium citrate (Drug)
RBCL
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days
干预措施: Clarithromycin (Drug)
RBCL
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days
干预措施: Levofloxacin (Drug)
RBLM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days
干预措施: Rabeprazole (Drug)
RBLM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days
干预措施: Bismuth potassium citrate (Drug)
RBLM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days
干预措施: Metronidazole (Drug)
RBLM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days
干预措施: Levofloxacin (Drug)
RBCM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days
干预措施: Rabeprazole (Drug)
RBCM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days
干预措施: Bismuth potassium citrate (Drug)
RBCM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days
干预措施: Metronidazole (Drug)
RBCM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days
干预措施: Clarithromycin (Drug)
RA
Rabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Rabeprazole (Drug)
RA
Rabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Amoxicillin (Drug)
RAB
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Rabeprazole (Drug)
RAB
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Bismuth potassium citrate (Drug)
RAB
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Amoxicillin (Drug)
RAM
Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Rabeprazole (Drug)
RAM
Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Metronidazole (Drug)
RAM
Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Amoxicillin (Drug)
RBAM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Rabeprazole (Drug)
RBAM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Bismuth potassium citrate (Drug)
RBAM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Metronidazole (Drug)
RBAM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Amoxicillin (Drug)
RBAM4
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Rabeprazole (Drug)
RBAM4
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Bismuth potassium citrate (Drug)
RBAM4
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Amoxicillin (Drug)
RBAM4
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days
干预措施: Metronidazole (Drug)
RBDM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days
干预措施: Rabeprazole (Drug)
RBDM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days
干预措施: Bismuth potassium citrate (Drug)
RBDM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days
干预措施: Metronidazole (Drug)
RBDM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days
干预措施: Doxycycline (Drug)
RBTM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days
干预措施: Rabeprazole (Drug)
RBTM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days
干预措施: Bismuth potassium citrate (Drug)
RBTM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days
干预措施: Metronidazole (Drug)
RBTM
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days
干预措施: Tetracycline (Drug)
结局指标
主要结局
Eradication rate of Helicobacter pylori
时间窗: 6 weeks
Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).
次要结局
- Eradication rate of Helicobacter pylori susceptible strains(6 weeks)
- Eradication rate of Helicobacter pylori resistant strains(6 weeks)