14-day PCAB-based and Reverse Hybrid Therapy Fro Helicobacter Pylori
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 906
- 试验地点
- 1
- 主要终点
- the rate of Helicobacter pylori
研究概览
简要总结
- Test for Helicobacter pylori. The test items include urease test, histology, bacterial culture, serology, and urea breath test. At least two positive results can be used to confirm the diagnosis.
- To ensure that the research results are not artificially distorted, this trial is a randomized study. Random allocation (which means that the subjects will use the "random number table generated by a computer similar to the lottery" to determine the treatment group) accept one of the following schemes (1:1:1).
详细描述
Helicobacter pylori (H.pylori) infect more than 50% of humans globally. This study were (1) to test whether the efficacies of 14-day PCAB-based high-dose dual therapy and 14-day PPI-based reverse hybrid therapy can achieve a higher eradication rate than 14-day PCAB-based triple therapy in the first-line treatment of H pylori infection, (2) to compare the eradication rates of 14-day PCAB-based and PPI-based bismuth quadruple therapies in the second-line treatment of H pylori infection, and (3) to examine the impacts of antibiotic resistance of H pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H pylori treatments.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects infected with Helicobacter pylori.
排除标准
- •Those who have ever received Helicobacter pylori sterilization treatment.
- •Those who are allergic to the drugs used in this research.
- •Those who have had stomach surgery.
- •Those with severe liver cirrhosis or uremia or malignant tumors.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
14th Rabeprazole reverse mixed therapy
first 7 days rabeprazole 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid and metronidazole 500mg bid Next 7 days rabeprazole 20mg bid and amoxicillin 1gm bid
干预措施: Rabeprazole, Amoxicillin, Clarithromycin and Metronidazole (Drug)
14-day vonoprazan high-dose two-in-one therapy
vonoprazan 20mg bid and amoxicillin 750mg qid
干预措施: Vonoprazan and Amoxicillin (Drug)
14-day vonoprazan triple therapy
vonoprazan 20mg bid and amoxicillin 1gm bid and clarithromycin 500mg bid
干预措施: Vonoprazan, Amoxicillin and Clarithromycin (Drug)
结局指标
主要结局
the rate of Helicobacter pylori
时间窗: 6 week after finishing study drugs
Evaluate eradication outcome by 13C uear breath test
次要结局
- Adverse drug reactions(2weeks after finishing study drugs)
研究者
DENG-CHYANG WU
Clinical Professor
Kaohsiung Medical University