Strategy on the Increment of H. Pylori Eradication Rate and Investigating the Gastric Pathology and Antimicrobial Resistance in Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel 10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients with Helicobacter pylori infection
排除标准
- •Pregnancy or physically poor performance status
- •Patients with contraindication for upper endoscopy
- •Severe coagulopathy for endoscopic biopsy
- •Chronic kidney disease (eGFR < 50) or end stage renal disease
- •Known allergy to interventional drugs
- •Previous eradication failure
研究组 & 干预措施
Sequential
Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day5 Metronidazole 500 mg BID day6~day10 Clarithromycin 500 mg BID day6~day10
干预措施: Amoxicillin (Drug)
Levofloxacin-based concomitant
Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day10 Metronidazole 500 mg BID day1~day10 Levofloxacin 500 mg QD day1~day10
干预措施: Pantoprazole (Drug)
Levofloxacin-based concomitant
Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day10 Metronidazole 500 mg BID day1~day10 Levofloxacin 500 mg QD day1~day10
干预措施: Amoxicillin (Drug)
Levofloxacin-based concomitant
Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day10 Metronidazole 500 mg BID day1~day10 Levofloxacin 500 mg QD day1~day10
干预措施: Metronidazole (Drug)
Levofloxacin-based concomitant
Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day10 Metronidazole 500 mg BID day1~day10 Levofloxacin 500 mg QD day1~day10
干预措施: Levofloxacin (Drug)
Sequential
Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day5 Metronidazole 500 mg BID day6~day10 Clarithromycin 500 mg BID day6~day10
干预措施: Pantoprazole (Drug)
Sequential
Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day5 Metronidazole 500 mg BID day6~day10 Clarithromycin 500 mg BID day6~day10
干预措施: Metronidazole (Drug)
Sequential
Pantoprazole 40 mg BID day1~day10 Amoxicillin 1000 mg BID day1~day5 Metronidazole 500 mg BID day6~day10 Clarithromycin 500 mg BID day6~day10
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: 1-4 months after eradication therapy
C13-UBT to confirm the H. pylori eradication
次要结局
- Intestinal metaplasia(1-4 weeks after gastric tissue obtained by upper endoscopy)
- Spasmolytic polypeptide expressing metaplasia(1-4 weeks after gastric tissue obtained by upper endoscopy)
- H. pylori resistance panel(1-4 weeks after H. pylori culture obtained by upper endoscopy)
- Acute inflammatory score(1-4 weeks after gastric tissue obtained by upper endoscopy)
- Chronic inflammatory score(1-4 weeks after gastric tissue obtained by upper endoscopy)
- H. pylori density score(1-4 weeks after gastric tissue obtained by upper endoscopy)
研究者
Chung-Tai Wu
National Cheng-Kung University Hospital
National Cheng-Kung University Hospital