ANTERO-3: The Impact of Enteral Nutrition Infusion Rate on Gastric Motility and Gastric Emptying Rate, Measured With the VIPUN Balloon Catheter, Magnetic Resonance Imaging and the 13C-octanoate Breath Test.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Motility
研究概览
简要总结
A complex neurohumoral feedback mechanism regulates gastric emptying of enteral nutrition through changes in gastric motility. In this investigation, we aim to investigate the impact of different infusion rates of enteral nutrition on gastric motility, gastric emptying rate, epigastric symptoms and satiation.
Additionally, magnetic resonance imaging will be used to validate an extended 13C-octanoate breath test for gastric emptying of a liquid test meal that is infused over 2 hours. Furthermore, the reliability of a manual position check of the VIPUN Balloon catheter will be confirmed with radiographic imaging. Finally, the data will be used for the data driven optimization of the VIPUN MI algorithm.
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
- 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
- •Signed Informed Consent
- •At least 18 years old
- •BMI between and including 18 and 30
- •Understand and able to read Dutch
- •In good health on the basis of medical history
- •Female subjects of childbearing potential are willing to use adequate contraception
- •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)
- •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
- •History of thermal or chemical injury to upper respiratory tract or esophagus
- •Current esophageal or nasopharyngeal obstruction
- •Known coagulopathy
- •Known esophageal varices
- •Metal or other MRI incompatible implants
- •Contra-indications for MR (checked by MR safety questionnaire)
- •Pregnancy
- •Claustrophobia
- •Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Isosource Standard.
研究组 & 干预措施
Condition A
- Infusion rate = 25 ml/h
- Radiography: confirmation balloon position
- VIPUN Balloon Catheter
- 13C-Octanoate Breath Test o
干预措施: VIPUN Balloon Catheter (Device)
Condition B
- Infusion rate = 75 ml/h
- Magnetic resonance imaging
- VIPUN Balloon Catheter
- 13C-Octanoate Breath Test
干预措施: VIPUN Balloon Catheter (Device)
Condition C
- Infusion rate = 250 ml/h
- Magnetic resonance imaging
- VIPUN Balloon Catheter
- 13C-Octanoate Breath Testt
干预措施: VIPUN Balloon Catheter (Device)
结局指标
主要结局
Motility
时间窗: 8 hour
Motility index (MI) measured with the VIPUN Balloon Catheter.
Gastric emptying rate (13C-Octanoate Breath Test)
时间窗: 8 hour
Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test.
Gastric emptying rate (Magnetic resonance imaging)
时间窗: Conditions B and C: 4 hour.
Gastric emptying rate of liquid test meal, measured with magnetic resonance imaging
次要结局
- Safety profile VIPUN Balloon Catheter(Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks)
- Feasibility VIPUN Balloon Catheter related procedures(Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks)
- Reliability manual position check(Once for each subject (during Condition A only): Position of the inflated balloon is judged on the thorax Rx (t<0) prior to start motility recording (= reference time point, t=0).)
- Satiation(6 hour)
- Position catheter at t=480.(During Condition A only: at t=480 minutes (after cessation motility recording).)
- Epigastric symptoms(6 hours)
研究者
Prof Dr Jan Tack
Head of Clinic - Gastroenterology / Professor of Medicine / Principal Investigator
Universitaire Ziekenhuizen KU Leuven