Normal Values for Gastric Emptying in a 13C-octanoate Breath Test Using a Solid Test Meal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)
研究概览
简要总结
Healthy volunteers will ingest a 13C-octaoate containing test meal and 13C in expiratory air will be followed. Normal values will be calculated data of these tests.
详细描述
This is a clinical study for establishing reference values in a 13C-octanoate breath test and a 13C-sodium acetate breath test. Healthy volunteers (n=75) will eat a solid test meal of scrambled eggs and toast containing 13C-octanoate. 13C-content of exhaled air will be measured at baseline and followed for the next 4 hours. One week later, the healthy volunteers (n=75) will drink a standardized nutritional shake (Ensure Plus Vanille, Abbott) containing 13C-sodium acetate. 13C-content of exhaled air will be measured at baseline and for the next 4 hours. Estimated gastric emptying time will be calculated using established algorithms.
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
- •Subjects free of relevant abdominal complaints
- •Written informed consent
排除标准
- •Age under 18
- •Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders)
- •Known diabetes mellitus, scleroderma, neurological impairment or other major current disease
- •Subjects unable to stop medication that alters gut function for 1 week prior to the study, including anticholinergics, calcium canal inhibitors, beta blocker, prokinetics, proton-pump inhibitors, DDV-IV-Inhibitors, Inkretin-mimetica, non-steroidal anti-inflammatory drugs, macrolid antibiotics
- •Pregnancy beyond week 12 (no pregnancy test will be performed)
- •Involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion
- •Known allergy or intolerance against hen egg protein or gluten
研究组 & 干预措施
gastric emptying measurements
干预措施: Solid test meal, liquid test meal on two separate occations (Other)
结局指标
主要结局
Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)
时间窗: 4 hours after test meal
次要结局
- t50 according to Bluck & Coward (t50_Bluck)(4 hours after test meal)
- t50 according to Wagner & Nelson (t50_WN)(4 hours after test meal)
- Gastric emptying coefficient (GEC)(4 hours after test meal)