Bismuth Quadruple Therapy With Tetracycline Versus Doxycycline as Rescue Therapy for Helicobacter Pylori Infection: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 242
- 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 evaluate the efficacy and safety of proton pump inhibitor, bismuth, metronidazole, and either tetracycline or doxycycline for Helicobacter pylori rescue treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori.
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
- •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.
- •Have failed eradication treatment before.
排除标准
- •Have not received Hp eradication treatment.
- •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, PPI 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
RBMD group
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)
RBMD group
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)
RBMD group
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)
RBMD group
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)
RAMT group
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)
RAMT group
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)
RAMT group
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)
RAMT group
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: At least 4 weeks after completion of therapy
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 resistant strains(At least 4 weeks after completion of therapy)
- Eradication rate of Helicobacter pylori susceptible strains(At least 4 weeks after completion of therapy)