Healthy
Conditions
Keywords
Gastric motility
Brief summary
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.
Interventions
DEVICEVIPUN Balloon Catheter
The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.
Sponsors
Prof Dr Jan Tack
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Three-way crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying rate (Magnetic resonance imaging) | Conditions B and C: 4 hour. | Gastric emptying rate of liquid test meal, measured with magnetic resonance imaging |
| Motility | 8 hour | Motility index (MI) measured with the VIPUN Balloon Catheter. |
| Gastric emptying rate (13C-Octanoate Breath Test) | 8 hour | Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Success rate (pass/fail) (reliability) of the manual position check of the VIPUN balloon catheter |
| Satiation | 6 hour | Subjective satiation score at a 30-minute interval. Visual Analogue Scale (100 mm, 0=absent, 100= maximal sensation). |
| Epigastric symptoms | 6 hours | Subjective epigastric symptom scores at a 30-minute interval. 3 Visual Analogue Scales (100 mm, 0=absent, 100= maximal sensation). Scale 1: Nausea, Scale 2: Bloating, Scale 3: Pain. |
| Position catheter at t=480. | During Condition A only: at t=480 minutes (after cessation motility recording). | Qualitative assessment of the migration of the catheter over the course of the study procedures. |
| Safety profile VIPUN Balloon Catheter | Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks | Incidence, frequency, severity, seriousness and relatedness of AE's |
| Feasibility VIPUN Balloon Catheter related procedures | Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks | Success rate of completing the procedure (placement and removal VIPUN Balloon Catheter |
Countries
Belgium
Outcome results
None listed