Personalized Treatment for Refractory H Pylori Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Number of Participants in Which H. Pylori Was Eradicated
研究概览
简要总结
In this study, the investigators develop a personalized treatment according to culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori infection.
详细描述
They are categorized into three groups: (1) patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics), (2) patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics), and (3) patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent.
- •positive results of both rapid urease test and histology,
- •a positive result of Urea breath test,
- •or a positive result of culture
排除标准
- •ingestion of antibiotics, bismuth, or proton-pump inhibitor within the prior 4 weeks,
- •patients with allergic history to the medications used,
- •patients with previous gastric surgery,
- •the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
- •pregnant women.
研究组 & 干预措施
rabeprazole+3 antibiotics
patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days
干预措施: rabeprazole+3 antibiotics (Drug)
rabeprazole+bismuth+2 antibiotics
patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days
干预措施: rabeprazole+bismuth+2 antibiotics (Drug)
rabeprazole+amox+tetr+levo
patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days
干预措施: rabeprazole+amox+tetr+levo (Drug)
结局指标
主要结局
Number of Participants in Which H. Pylori Was Eradicated
时间窗: eight weeks after the end of anti-H pylori therapy
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.
次要结局
未报告次要终点
研究者
Ping-I (William) Hsu, M.D.
Professor
Kaohsiung Veterans General Hospital.