The Effect of High PCO2 Solution on Esophageal Acid Sensation in Healthy Patients Versus Those With Non-Erosive Reflux Disease.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- The Mechanism of GERD
研究概览
简要总结
To determine the effect of intraesophageal high PCO2 solution as compared to acidic and saline solutions on subjects' heartburn sensation using stiumlus-response functions.
详细描述
Presently, the exact mechanism of GERD and the role of CO2 in pathogenesis of heartburn symptoms is unclear. CO2 conversion to protons may play a key role in the mechanism for heartburn sensation. This is a prospective, randomized study that will help further explore the mechanism for heartburn sensation in GERD patients and can be a prelude for further studies examining the role of new class antireflux agents such as carbonic anhydrase inhibitors in the treatment of patients with heartburn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10 Healthy Controls
- •Normal EGD, Normal 24-hr pH
- •18-80 Years of age
- •Able to read, understand and complete study questionnaires and diary
- •Able to understand study procedures and sign informed consent
- •Albe to comply with all study requirements
- •10 NERD (Non-Erosive Reflux Disease)
- •18-80 Years of age
- •Willing to stop PPI/H2 Blocker prior to EGD
- •Have heartburn symptoms 2+ times per week for at least 3 months.
排除标准
- •Esophageal erosions, Barretts, or peptic stricture on EGD
- •Previous esophageal, gastric or duodenal surgery
- •underlying co-morbidities
- •Diabetes mellitus (requires insulin), scleroderms, or neuromuscular disorder
- •Upper airway symptoms
- •Tricyclic antidepressants, antispasmodics, selective serotonin receptor inhibitors, thiazides, bile acid-binding agents or prokinetics
- •Patients who cannot or are unwilling to sign ICF
结局指标
主要结局
The Mechanism of GERD
时间窗: NA There is no exact timeframe.
Presently the exact mechanism of GERD and the role of CO2 in pathogenesis of heartburn sysmptoms is unclear. We aim to compare the effect of intraesophageal high PCO2 solution with saline solution on heartburn sensation.
次要结局
未报告次要终点