Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The incidence and severity of acid-related symptoms with GerdQ
研究概览
简要总结
Background: Rebound acid hypersecretion and acid-related symptoms after discontinuation of proton-pump inhibitor has been reported in previous studies. In patients with concurrent gastro-esophageal reflux disease and Helicobacter pylori infection, whether eradication of Helicobacter pylori (H. pylori)will aggravate acid-related symptoms after discontinuation of proton-pump inhibitor remains elusive Objective: This study aims to investigate the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication.
详细描述
Background: Rebound acid hypersecretion and acid-related symptoms after discontinuation of proton-pump inhibitor has been reported in previous studies. In patients with concurrent gastro-esophageal reflux disease and Helicobacter pylori infection, whether eradication of H. pylori will aggravate acid-related symptoms after discontinuation of proton-pump inhibitor remains elusive Objective: This study aims to investigate the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor in reflux patients receiving H. pylori eradication Patients and methods: Consecutive reflux patients documented by validated questionnaires (GerdQ) and upper endoscopy will be enrolled from the outpatient clinic. After determination of H. pylori status by urea breath test, those with positive H. pylori infection will be randomized into two groups. Group A (n=100) will be given initial H. pylori eradication with triple therapy for one week, followed by proton-pump inhibitor (PPI) with rabeprazole 20 mg qd for 7 weeks. Group B (n=100) will be given rabeprazole 20 mg qd for 8 weeks and discontinued for 2 weeks. Then, H. pylori eradication with triple therapy will be given for one week, followed by rabeprazole 20 mg qd for 7 weeks. For patients with negative H. pylori infection (n=100), proton-pump inhibitor with rabeprazole 20 mg qd will be given for 8 weeks and discontinued. The incidence and severity of acid-related symptoms will be evaluated with GerdQ at 2 weeks after discontinuation of PPI. The impact of H. pylori infection and H. pylori eradication on the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients with typical reflux symptoms (heartburn and/or acid regurgitation) validated by standard questionnaire GerdQ.16
- •Aged from 18 to 70 years old.
- •Willing to receive H. pylori eradication therapy.
排除标准
- •Symptomatic reflux patients with high grade erosive esophagitis ( Los Angeles classification Grade C and D) or Barrett's esophagus documented by endoscopy.
- •Symptomatic reflux patients with a history of using PPI in recent one month.
- •Subjects with known allergy to PPI.
- •Peptic ulcer disease
- •Cancers of the esophagus, stomach, and duodenum
- •Esophageal or gastric varices
- •Active upper gastrointestinal bleeding within 7 days prior to enrollment
- •Status after total or subtotal gastrectomy
- •Use of anticoagulants or antiplatelets within one week prior to enrollment
- •Subjects with bleeding tendency
结局指标
主要结局
The incidence and severity of acid-related symptoms with GerdQ
时间窗: 2 weeks after PPI
To compare the incidence and severity of acid-related symptoms after discontinuation of proton-pump inhibitor between reflux patients with and without H. pylori infection
次要结局
未报告次要终点
