Esomeprazole / Vonoprazan Combined With High-dose Amoxicillin Dual Therapy for Primary Eradication of Helicobacter Pylori Infection: a Multi-center, Prospective, Open-label, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 806
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
This study intends to collect the clinical data of patients with Helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate traditional quadruple therapy or Vonoprazan + amoxicillin double high-dose double therapy and Vonoprazan + amoxicillin + clarithromycin triple therapy ). The eradication rate of Helicobacter pylori was compared between the two different regimens respectively, and the efficacy, safety and compliance of different regimens were compared. It provides a new reference for clinical treatment of Helicobacter pylori, and has great clinical value and significance for simplifying the anti-Helicobacter-pylori treatment plan, increasing patient compliance, and exploring efficient anti-Helicobacter-pylori therapy suitable for the Chinese population.
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
- 14 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 14-90 years, no requirement for gender;
- •patients diagnosed as H. pylori infection by at least one of the following tests: carbon-13/14 urea breath test (13C/14C-UBT) or immuno-histochemical staining of biopsy specimens;
- •patients with no use of antibiotics, bismuth or Chinese traditional medicines with antibacterial effects in the previous 4 weeks of 13C/14C-UBT, and no H2 receptor antagonists, PPIs, P-CAB or other drugs affecting H .pylori activity within the previous 2 weeks of 13C/14C-UBT;
- •patients without history of receiving H. pylori eradication therapy.
排除标准
- •patients with serious diseases or clinical conditions that may interfere with the evaluation of the results of the study, such as severe heart, liver, lung, and renal insufficiency, low immunity, and so on;
- •patients with allergy to penicillin or any research-program-related drugs;
- •patients with mental illness and communication disorders;
- •patients in pregnancy or lactation;
- •patients with severe gastrointestinal diseases, such as gastrointestinal tumors, gastrointestinal bleeding, other organic diseases, etc.;
- •patients who were participating in other clinical trials;
- •patients who were considered inappropriate for enrollment after evaluation by the researchers.
研究组 & 干预措施
Double group ( Esomeprazole )
干预措施: esomeprazole + amoxicillin (Drug)
Quadruple group ( Esomeprazole )
干预措施: esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate agent (Drug)
Double group ( Vonoprazan )
干预措施: Vonoprazan + amoxicillin (Drug)
Triple group (Vonoprazan )
干预措施: Vonoprazan + amoxicillin + clarithromycin (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: pre-intervention and at least 30 days post-intervention
carbon-13/14 urea breath test
次要结局
- Adverse events(the 3rd, 7th, and 14th day during the intervention)
- Compliance(the 14th day during the intervention)
研究者
Fen Wang
Professor
The Third Xiangya Hospital of Central South University