Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 579
- 试验地点
- 1
- 主要终点
- HP eradication rate
研究概览
简要总结
It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.
详细描述
It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years old;
- •Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;
- •Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
- •Voluntarily join this trial and sign the informed consent form.
排除标准
- •Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);
- •Patients with confirmed active peptic ulcer;
- •Patients who have received Helicobacter pylori eradication therapy within half a year;
- •Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;
- •Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;
- •History of esophageal or gastric surgery;
- •Pregnant or lactating women;
- •Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
- •Hepatic insufficiency caused by hepatitis, fatty liver and other reasons;
- •Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.
研究组 & 干预措施
Group A Bismuth quadruple
Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth, treatment course 14 days
干预措施: Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days (Drug)
Group B Amoxicillin Dual therapy
Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid , treatment course 14 days
干预措施: Vonoprazan+Amoxicillin (Drug)
Group C doxycycline Dual therapy
Vonoprazan 20 mg, bid +doxycycline 0.1 g, bid，treatment course 14 days
干预措施: Vonoprazan+doxycycline (Drug)
结局指标
主要结局
HP eradication rate
时间窗: 4-6 weeks after the end of the last dose
The eradication effect of Helicobacter pylori was tested by 13C-UBT or 14C-UBT
次要结局
- Patient compliance(Within 3 days after the end of treatment)
研究者
Zhenyu Zhang
Director of Gastroenterology
Nanjing First Hospital, Nanjing Medical University