Efficacy Comparison of Metronidazole-based Triple and Bismuth-based Quadruple Therapy for Clarithromycin Resistant-Helicobacter Pylori Infection: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 782
- 试验地点
- 1
- 主要终点
- H. pylori eradication rate
研究概览
简要总结
Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. 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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •peptic ulcer disease
- •H. pylori gastritis
- •low grade MALT lymphoma
排除标准
- •history of gastric cancer surgery
- •severe comorbidity (ESRD, LC)
- •hypersensitivity to drug
- •pregnancy
研究组 & 干预措施
PAM
treatment with PPI, metonidazole, amoxicillin
干预措施: PAM (Drug)
PBMT
treatment with PPI, metonidazole, bismuth, tetracyclin
干预措施: PBMT (Drug)
结局指标
主要结局
H. pylori eradication rate
时间窗: 14 days
H. pylori eradication rate
次要结局
未报告次要终点
研究者
Shin, Woon Geon
Woon Geon Shin
Kangdong Sacred Heart Hospital
