Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Number of Impedance Episodes Following PPI and Placebo
研究概览
简要总结
The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on the total number of reflux episodes in the distal esophagus measured by impedance in patients with and without gastroesophageal reflux disease (GERD) based on 24-hour pH testing. In addition to changing the acidity of the refluxate, the investigators hypothesize that PPIs also reduce the total number of reflux episodes due to its anti-secretory effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adults patients (age 18 or older) with reflux symptoms willing to participate
排除标准
- •Pregnancy
- •Prior esophageal or gastric surgery
- •Achalasia
- •Scleroderma
- •Gastroparesis.
研究组 & 干预措施
Placebo arm
Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes
干预措施: placebo (Drug)
Esomeprazole
Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Number of Impedance Episodes Following PPI and Placebo
时间窗: 1 week
Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.
次要结局
未报告次要终点
研究者
Fouad Moawad
Gastroenterologist
Walter Reed National Military Medical Center