Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Eradication rate of Helicobacter pylori
研究概览
简要总结
Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.
详细描述
Antibiotics resistant is serious problem in helicobacter pylori eradication. Clarithromycin is very important antibiotics in eradication. But clarithromycin resistance is increased. Major cause of clarithromycin resistance is past consumption of macrolide. Thus the investigators propose eradication of macrolide used group bismuth contained four drugs therapy.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peptic ulcer disease
- •Gastric MALT lymphoma
- •Early gastric cancer
- •Familial history of gastric cancer
- •Idiopathic iron deficiency
- •Chronic idiopathic thrombocytopenia
- •Atrophic gastritis
- •Helicobacter infected dyspepsia
- •Long term NSAIDs use
排除标准
- •Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks
- •Previous stomach surgery
- •Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder)
- •Previous Helicobacter eradication
- •Allergy for Helicobacter eradication medicine
研究组 & 干预措施
Experimental
Omeprazole 30mg twice Clarithromycin 500mg twice Amoxicillin 1000mg twice
for 10 days
干预措施: Helicobacter pylori eradication (Drug)
Control
Tetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days
干预措施: Helicobacter pylori eradication (Drug)
结局指标
主要结局
Eradication rate of Helicobacter pylori
时间窗: one month
次要结局
未报告次要终点
研究者
Sun Gyo Lim
Assistant professor
Ajou University School of Medicine