Gastric Motility
Conditions
Brief summary
It has been demonstrated that the VIPUN Gastric Monitoring System (GMS) can discriminate healthy physiological and pharmacologically-inhibited gastric motility, using a codeine-model in healthy adults (S60320 / AFMPS80M0687). Erythromycin is a gastroprokinetic agent, known to stimulate gastric contractility. A single dose of 200 mg erythromycin has been shown to induce a prolonged period of enhanced phasic contractile activity. The primary aim of this investigation is to validate the ability of the VIPUN GMS to discriminate between normal and pharmacologically-enhanced fasting gastric motility in healthy adults. The performance of the VIPUN GMS can be enhanced by data-driven optimization of the VIPUN Motility Algorithm, used to quantify gastric motility.
Interventions
DEVICEVIPUN GMS
Motility is measured for 4 hours with the VIPUN Gastric Monitoring System (GMS).
Test model: Erythromycin has gastroprokinetic properties. The primary aim of this investigation is to validate the ability of the VIPUN GMS to discriminate between normal and pharmacologically-enhanced fasting gastric motility in healthy adults. Erythromycin Lactobionate infusion: 200 mg i.v. infusion over a period of 20 minutes. Note: Erythromycin is not labeled as a gastroprokinetic agent in Belgium.
Sponsors
Prof Dr Jan Tack
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
A gastroprokinetic agent is administered to stimulate gastric motility.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed Informed Consent * Aged between and including 18 and 65 years * BMI between and including 18 and 30 * 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
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 * 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 * Pregnant or breastfeeding women * Have known side-effects/allergic reactions when taking erythromycin or other macrolide antibiotics (such as azithromycin, clarithromycin) * Kidney disease * Liver disease * Myasthenia gravis * QT prolongation (QT ≥400 ms) at the screening * Cardiac arrhythmia or heart failure * History of C. difficile infection * Family history of QT prolongation, sudden cardiac death or other heart problems * Recent vaccinations with live bacterial vaccines (such as typhoid vaccine) * Concomitant medication use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GBMI baseline | t = 0 - 119 minutes | Gastric Balloon Motility Index (GBMI) is measured with the VIPUN Gastric Monitoring System. GBMI is a value between 0 and 1. |
| GBMI120 - 139 | t = 120 - 139 minutes | Motility during erythromycin administration. Gastric Balloon Motility Index (GBMI) is measured with the VIPUN Gastric Monitoring System. GBMI is a value between 0 and 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | t = 0 - 240 minutes | Incidence of adverse events |
| Severity of adverse (device) events/effects | t = 0 - 240 minutes | Severity of adverse (device) events/effects |
| Seriousness of adverse (device) events/effects | t = 0 - 240 minutes | Seriousness of adverse (device) events/effects |
| GBMI140-240 | t = 140 - 240 minutes | Motility in the period 140 - 240 minutes. Gastric Balloon Motility Index (GBMI) is measured with the VIPUN Gastric Monitoring System. GBMI is a value between 0 and 1. |
| Incidence of device deficiencies of the investigational medical device | t = 0 - 240 minutes | Qualitative description of the event, onset, duration, origin, action taken and outcome of the event |
| Incidence of protocol deviations related to the investigational medical device | t = 0 - 240 minutes | Qualitative description of the event, onset, duration, origin, action taken and outcome of the event |
| Relatedness of adverse (device) events/effects | t = 0 - 240 minutes | Relatedness of adverse (device) events/effects |
| Symptoms | t = 0 - 240 minutes | Epigastric symptoms (nausea, bloating, pain) are surveyed with Visual Analogue Scales for severity of each individual symptom (100 mm, 0 = Absent to 100 mm = worst possible sensation) at a 15 minute interval. |
Countries
Belgium
Outcome results
None listed