A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying During Continuous Nutrient Infusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Hourly 13C-recovery
研究概览
简要总结
The objective of this dose-finding and feasibility study is to establish the optimal 13C-octanoate concentration to be used with slowly infused enteral nutrition to perform a prolonged gastric emptying test using the breath test. More specifically, the aim is to discover the 13C-octanoate concentration that induces a steady state hourly 13C-recovery. This would allow to implement the prolonged breath test protocol in a future clinical investigation in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Signed Informed Consent
- •At least 18 years old
- •BMI between and including 18 and 29
- •Understand and able to read Dutch
- •In good health on the basis of medical history
- •Refrains from herbal, vitamin and other dietary supplements on the day of the visits
排除标准
- •Dyspeptic symptoms (assessed with PAGI-SYM questionnaire, Annex II)
- •Using any medication that might affect gastric function or visceral sensitivity
- •Known / suspected current use of illicit drugs
- •Known psychiatric or neurological illness
- •Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
- •History of heart or vascular diseases like irregular heartbeats, angina or heart attack
- •Nasopharyngeal surgery in the last 30 days
- •Suspected basal skull fracture or severe maxillofacial trauma
- •History of thermal or chemical injury to upper respiratory tract or esophagus
- •Current esophageal or nasopharyngeal obstruction
- •Known coagulopathy
- •Known esophageal varices
- •Have a known allergy or intolerance to cow milk, soy or any other ingredient of Isosource Standard.
- •Known galactosaemia
研究组 & 干预措施
Concentration A
Concentration of 13C-sodium octanoate in enteral nutrition is 0.3 mg/ml
干预措施: 13C-octanoate breath test for gastric emptying (Diagnostic Test)
Concentration B
Concentration of 13C-sodium octanoate in enteral nutrition is 1.0 mg/ml
干预措施: 13C-octanoate breath test for gastric emptying (Diagnostic Test)
Concentration C
Concentration of 13C-sodium octanoate in enteral nutrition is 3.0 mg/ml
干预措施: 13C-octanoate breath test for gastric emptying (Diagnostic Test)
结局指标
主要结局
Hourly 13C-recovery
时间窗: 8 hour
Indicator for gastric emptying rate
次要结局
未报告次要终点
研究者
Prof Dr Jan Tack
prof. dr.
Universitaire Ziekenhuizen KU Leuven