A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- the eradication rate of the two groups
研究概览
简要总结
We aim to assess and compare the effectiveness of clarithromycin- and furazolidone-based regimens as primary therapies in eradicating H. pylori.
详细描述
Helicobacter pylori plays a pivotal role in many diseases such as peptic ulcer disease and MALT lymphomas. And the prevalence of H. pylori is increasing in some parts of the world.
However, the eradication becomes increasingly difficult due to the growing antibiotic resistance. Bismuth-containing quadruple regimens are now recommended to serve as first-line therapies. Bismuth-clarithromycin-containing and bismuth-furazolidone-containing quadruple regimens are both in the list of the first regimens. And recent antimicrobial susceptibility tests showed us that the clarithromycin was increasingly resisted while furazolidone remained hardly resisted. The comparison between the effects of bismuth-clarithromycin-containing and bismuth-furazolidone-containing quadruple regimens is not so clear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, aged between 18 and 75years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.
排除标准
- •Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
研究组 & 干预措施
bismuth-clarithromycin-containing group
Patients in bismuth-clarithromycin-containing group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and clarithromycin (Klacid) 500mg po bid for 14d
干预措施: Clarithromycin (Drug)
bismuth-furazolidone-containing quadruple group
patients in bismuth-furazolidone-containing quadruple group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 240mg po bid, and furazolidone (Liteling) 100mg po bid for 14d
干预措施: Furazolidone (Drug)
结局指标
主要结局
the eradication rate of the two groups
时间窗: 26 months
次要结局
未报告次要终点
研究者
Xiuli Zuo
director of Qilu Hospital gastroenterology department
Shandong University