NCT01453036已完成4 期
Eradication of Helicobacter Pylori According to 23S rRNA Point Mutations Associated With Clarithromycin Resistance
Jin Il Kim2 个研究点 分布在 1 个国家目标入组 924 人开始时间: 2011年8月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 924
- 试验地点
- 2
- 主要终点
- Helicobacter Pylori Eradication Rate
研究概览
简要总结
- Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23S rRNA point mutation of Helicobacter pylori is associated clarithromycin resistance
- Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment regimens containing a proton pump inhibitor and combination of two antibiotics (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate Helicoabacter pylori more successfully
- Material & methods The investigators enroll patients diagnosed with peptic ulcer, endoscopically. Helicobacter pylori is documented with Urea breath test or silver staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation, the investigators consider as resistance to clarithromycin and choose the treatment regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin, clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare eradication rate with conventional treatment,proton pump inhibitor, amoxicillin, clarithromycin.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 - 75 years old
- •Peptic ulcer (gastric ulcer, duodenal ulcer)
- •Helicobacter pylori positive
排除标准
- •Major comorbidities
- •Pregnancy
- •History of Helicobacter pylori eradication
- •History of gastric surgery or other cancers, except to endoscopic treatment due to gastric lesion
结局指标
主要结局
Helicobacter Pylori Eradication Rate
时间窗: 8 weeks
Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.
次要结局
未报告次要终点
研究者
Jin Il Kim
professor
The Catholic University of Korea
研究点 (2)
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