Comparison of the Efficacy of Sequential Therapy and Bismuth Quadruple Therapy in the First Line and Second Line Therapy for Helicobacter Pylori Infection- A Multi-center Randomized Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 620
- 试验地点
- 7
- 主要终点
- Eradication rate: determined by urea breath test (13C-UBT, according to ITT analysis)
研究概览
简要总结
The investigators aimed to
- compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the first line and second line treatment
- assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
- assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
- assess the impact of eradication therapy on the metabolic factors
详细描述
Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection reduces the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. Sequential therapy for 10 days has been shown to be more effective than triple therapy for 7 and 10 days. The investigators further demonstrated that sequential therapy given for 14 days was superior to triple therapy given for 14 days. Recently, the investigators also found that bismuth quadruple therapy given for 10 days appeared to be more effective than triple therapy given for 14 days in the first line therapy. However, whether sequential therapy given for 14 days is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •H. pylori infected patients naïve to eradication therapies will be eligible in this study.
排除标准
- •children and teenagers aged less than 20 years,
- •history of gastrectomy,
- •gastric malignancy, including adenocarcinoma and lymphoma,
- •previous allergic reaction to antibiotics (bismuth, amoxicillin, metronidazole, clarithromycin, tetracycline) and PPI (esomeprazole),
- •contraindication to treatment drugs,
- •pregnant or lactating women,
- •severe concurrent disease,
- •concomitant use of clopidogrel, or (9) Unwilling to accept random assignment of subjects
研究组 & 干预措施
sequential therapy for 14 days (S14)
14 day sequential therapy
干预措施: 14-day sequential therapy (Drug)
bismuth quadruple therapy (Q10)
Bismuth quadruple therapy
干预措施: Bismuth quadruple therapy (Drug)
结局指标
主要结局
Eradication rate: determined by urea breath test (13C-UBT, according to ITT analysis)
时间窗: 6 weeks
No eradicated divided by total cases by intention to treat analysis. 13C-UBT will be used to determine the H. pylori status at least 6 weeks after completion of treatment. A delta value of \> 4 units will be defined as positive for H. pylori infection as our previous studies.
次要结局
- changes of antibiotic resistance(2 weeks, 8 weeks, 1 year)
- adverse effect: occurrence of any adverse effect during the treatment(2 weeks)