Optimal Recheck Time for Helicobacter Pylori Eradication: A Prospective, Single-center, Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- the eradication rate in each group (ITT analysis)
研究概览
简要总结
Although Urea breath test has been commonly used to recheck the efficiency of Helicobacter pylori eradication, there has been no randomized trials comparing the accuracy of Urea breath test results at different times after eradication. The investigators aim to assess the accuracy and influence factors of post-therapy test at different times and follow up the cut off samples to optimize the best time to recheck.
详细描述
The investigators plan to conduct a single-center, open-label, randomized controlled study in Zhejiang, China. Treatment-naive H. pylori-positive participants (n = 900) were randomly assigned to three groups in a 1:1:1 ratio with the same eradication regimen: amoxicillin 1000 mg, clarithromycin 500mg, rabeprazole 10mg, and colloidal bismuth 200 mg each given twice a day for 14 days. Urea breath tests were administered at different times after the treatment: 4 to 6 weeks, 6 to 8 weeks, and 8 to 10 weeks, respectively, for different groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no history of helicobacter pylori treatment
- •the diagnosis of H. pylori infection was confirmed by one or more of the following methodologies before treatment: gastric biopsy using histochemical staining, tissue culture, the 14C-urea breath test (UBT), and/or the 13C-UBT.
排除标准
- •used antibiotics or bismuth within four weeks before inclusion or acid inhibitor use, including H2 receptor antagonist (H2RA), PPI or P-CAB use, within two weeks prior to inclusion.
- •had an active peptic ulcer with complications such as hemorrhage, perforation, or obstruction.
- •had a history of esophagectomy or gastrectomy.
- •had an allergy to any study drug.
- •had severe comorbidities or physical or mental diseases.
- •were pregnant or breastfeeding.
- •had a history of alcohol abuse or drug addiction.
结局指标
主要结局
the eradication rate in each group (ITT analysis)
时间窗: up to 4 months after eradication therapy
According to the breath urea test, calculation the eradication rate in the three groups. ITT analysis, the number of negative breath test cases after treatment divided by the number of cases enrolled in eradication therapy.
the eradication rate in each group (PP analysis)
时间窗: up to 4 months after eradication therapy
According to the breath urea test, calculation the eradication rate in the three groups. PP analysis, the number of negative breath test cases after treatment divided by the number of cases finished the eradication therapy
次要结局
- follow up of cut off cases(up to 4 months after eradication therapy.)