Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Identify normal esophageal MII-pH parameter ranges in healthy volunteers
研究概览
简要总结
The normal values of a Multichannel Intraluminal Impedance (MII)-pH study can vary between ages, gender, race and different values of body mass index (BMI). This fact can cause new modifications in the normal values such as making new scales for different age groups or BMI groups.
Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never experienced reflux related symptoms and are in between the same ranges of age and BMI of our gastroesophageal reflux disease (GERD) patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 33 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults between the ages of 33-65
- •BMI range of 23.9 - 38.9
- •Ability to give consent to participate in study
排除标准
- •History of extraesophageal reflux disease symptoms such as chronic or acute cough and/or throat clearing and /or non-cardiac chest pain.
- •History of gastroesophageal reflux disease (GERD) such as heartburn and/or regurgitation.
- •History of proton pump inhibitor (PPI) usage ten days prior to the procedure (MII-pH) or H2RA's two days prior to MII-pH and antacids usage on the procedure day.
- •History of thoracic, gastric or esophageal surgery.
- •Histories of Diabetes Mellitus, neurological disorders, gastrointestinal disease, taking medication that alter the intragastric acidity or esophageal motility.
- •Pregnancy or nursing mothers.
- •Alcohol consumption >40g/day, smoking >10cigarettes/day.
研究组 & 干预措施
Healthy Volunteers
Healthy volunteers who are matched (age, weight, gender) to the general patient population undergoing manometry and pH monitoring for GERD will undergo the same procedures to determine pH levels in people without reflux symptoms as compared to pH levels in those patients who have been diagnosed with reflux.
干预措施: 24-hr pH monitoring (Procedure)
结局指标
主要结局
Identify normal esophageal MII-pH parameter ranges in healthy volunteers
时间窗: Following 24-hr pH monitoring
Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never experienced reflux related symptoms and are in between the same ranges of age and BMI of our GERD patient population.
次要结局
未报告次要终点
研究者
Michael Vaezi
Medical Director
Vanderbilt University Medical Center