Normal Values for Esophageal High Resolution Manometry in an Advanced Protocol Using a Test Meal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Values for HRM data (IRP, DCI, DL) in healthy volunteers
研究概览
简要总结
Normal values for measurements of high resolution manometry in a protocol which includes isolated liquid swallows in upright and recumbent position, free drinking of water, a solid test meal and a postprandial observational period will be determined.
详细描述
The investigators will recruit healthy volunteers and ask for study participation. After providing informed consent, participants will be questioned using standardized questionnaires assessing symptoms of reflux, dysphagia, gastrointestinal symptom burden and depression. Participants will be tested using our advanced protocol for high resolution esophageal manometry. This protocol includes individual liquid swallows, free drinking of water, a standardized test meal (200g rice) and a postprandial observational period. Normal values for liquid and solid swallows will be determined.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers without gastrointestinal co-morbidity
排除标准
- •Inability or unwillingness to provide informed consent
- •Any relevant current or past gastrointestinal morbidity (including diseases relevant previous surgery).
- •Relevant gastrointestinal symptoms
- •Relevant medication (as specified below) within the last 4 weeks
- •Age below 18 years
研究组 & 干预措施
rice meal
High resolution manometry will be performed. Esophageal function will be tested using liquid swallows, solid swallows and a test meal (200g rice)
干预措施: Rice meal (Other)
结局指标
主要结局
Values for HRM data (IRP, DCI, DL) in healthy volunteers
时间窗: 1 hour
Normal values for measurements of high resolution manometry in a protocol which includes isolated liquid swallows in upright and recumbent position, free drinking of water, a solid test meal
次要结局
- discomfort on a VAS from 1-10 for each type of measurement(1 hour)