A Comparison of High-dose Dual Therapy and Half-dose Clarithromycin-containing Bismuth Quadruple Therapy for H.P Eradication in Elderly Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- eradication rate of the two groups
研究概览
简要总结
The purpose of this study is to assess and compare the effectiveness and safety of high-dose dual therapy and half-dose clarithromycin-containing bismuth quadruple therapy in elderly patients for eradicating H.pylori.
详细描述
Helicobacter pylori plays an important role in many diseases such as peptic ulcer disease and MALT lymphomas. And the prevalence of H. pylori remains high in developing countries,including China.
Clarithromycin-containing bismuth quadruple therapy has been recommended as the first-line therapy for H pylori infection in China. However, its expensive cost and high antibiotic-related adverse reactions are always haunting us. In 2018,a research from NanFang hospital(China）revealed that 250mg clarithromycin is as effective as 500mg clarithromycin，at the same time，causes less adverse reactions. On the othe hand,previous studies reported a new regimen called large dose dual therapy（generally contains a PPI and amoxicillin),while some of them have achieved very good results,especially in Taiwan.
However, specific data on anti-H.pylori treatments in elderly people are very lacking.So,we aim to assess and compare the effectiveness and tolerability of high-dose dual therapy and half-dose clarithromycin-containing bismuth quadruple therapy in elderly patients.Considering the difference of drug metabolism between eldery and young people，a satisfactory result may be obtained.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients, aged greater than 65 , 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
high dose dual group
Patients in high dose dual group will receive lansoprazole (Takepron) 30mg po qid, amoxicillin 750mg po qid for 14d
干预措施: Lansoprazole, Amoxicillin (Drug)
half-dose clarithromycin-containing bismuth quadruple group
Patients in half-dose clarithromycin-containing bismuth quadruple group will receive lansoprazole (Takepron) 30mg po bid, amoxicillin 1000mg po bid, bismuth subcitrate (Colloidal Bismuth Pectin) 200mg po bid, and clarithromycin (Klacid) 250mg po bid for 14d
干预措施: Lansoprazole, Amoxicillin,Clarithromycin and Bismuth subcitrate (Drug)
结局指标
主要结局
eradication rate of the two groups
时间窗: 24 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