Phase 4 Study of Helicobacter Pylori Eradication Therapy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)
研究概览
简要总结
The role of Helicobacter pylori infection in functional dyspepsia remains controversial. Several randomized controlled trials in western countries have shown no significant advantage over placebo. But some recent studies in Asian population were different compared to the result of studies in the Western population. At the present time, it seems to be difficult to conclude the efficacy of the H.pylori eradication therapy in patients with H. pylori-infected functional dyspepsia.
The investigators hypothesize that eradication of Helicobacter pylori has a sustained global symptom improvement in patients with H. pylori infected functional dyspepsia.
详细描述
Functional dyspepsia: diagnosed by Rome III criteria of Functional gastrointestinal disorder Treatment regimen: Combination of proton pump inhibitor, Amoxicillin, Clarithromycin for 7 days Placebo: Same shaped placebo drugs
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functional dyspepsia by Rome III criteria
- •Normal endoscopic findings
- •H. pylori positive by Urea breath test
排除标准
- •Patients with severe concomitant systemic disease
- •Patients with GI surgery
- •Females with pregnancy or breast-feeding
- •Irritable bowel syndrome, inflammatory bowel disease
- •Duodenal Ulcer, Gastric Ulcer, GI bleeding
- •History of eradication therapy of Helicobacter pylori
- •Malignancy
- •Psychosomatic disease
研究组 & 干预措施
Lansoprazole+Clarithromycin+Amoxycillin
Lansoprazole 30 mg bid, for 7 days Clarithromycin 500 mg bid, for 7 days Amoxicillin 1000 mg bid, for 7 days
干预措施: Lansoprzole+Amoxicillin+Clarithromycin (Drug)
结局指标
主要结局
Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)
时间窗: Symptom assessment at 8 weeks after eradication
次要结局
- To improves the quality of life(1 year)
- Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy(1 year)
- The improvement of 8 dyspeptic symptom(1 year)
- The adequate relief of symptom(1 year)