Unblinded Comparison Study for Relationship and Reproducibility Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring, in Patients With Acid-related Diseases and Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 24-hour gastric pH
研究概览
简要总结
The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Gastric Acid-related diseases like peptic ulcer or gastroesophageal reflux disease in investigator's judgment
- •Healthy subjects who are determined no history of Helicobacter pylori infections
排除标准
- •Patients with hypercalcemia
- •Patients with hypothyroidism
- •Patients with hyperparathyroidism
- •History of upper gastrointestinal surgery or resection
- •Any condition would limit the subject's ability to complete 24-hour gastric pH monitoring
研究组 & 干预措施
C13-CAC
干预措施: Calcium (13C)Carbonate (Drug)
结局指标
主要结局
24-hour gastric pH
时间窗: from completion of pre-study examination to before C13-CAC adminitration
Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration
13CO2 concentration in expired air
时间窗: 5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration
13CO2 concentration in expired air, 13CO2 excretion rate in expired air as well as the pharmacokinetic parameters (Cmax, AUCt, AUC∞, tmax, λz, and t1/2) determined from the 13CO2 concentration in expired air and 13CO2 excretion rate in expired air
次要结局
未报告次要终点