ANTERO-4: VIPUN Gastric Monitoring System in an Erythromycin Model

Study Overview
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Brief Summary
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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.

Official Title
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ANTERO-4: A Clinical Investigation of the Effects of Erythromycin on Gastric Motility, Assessed With the VIPUN Gastric Monitoring System in Healthy Adults

Conditions
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Gastric Motility

Intervention / Treatment
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* Device: VIPUN GMS
* Drug: Erythromycin Lactobionate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: A gastroprokinetic agent is administered to stimulate gastric motility.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIPUN GMS<br>Single arm study. | Device: VIPUN GMS<br>* Motility is measured for 4 hours with the VIPUN Gastric Monitoring System (GMS).<br>Drug: Erythromycin Lactobionate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GBMI baseline | Gastric Balloon Motility Index (GBMI) is measured with the VIPUN Gastric Monitoring System. GBMI is a value between 0 and 1. | t = 0 - 119 minutes | 
| GBMI120 - 139 | 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. | t = 120 - 139 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GBMI140-240 | 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. | t = 140 - 240 minutes | 
| Symptoms | 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. | t = 0 - 240 minutes | 
| Incidence of adverse events | Incidence of adverse events | t = 0 - 240 minutes | 
| Severity of adverse (device) events/effects | Severity of adverse (device) events/effects | t = 0 - 240 minutes | 
| Seriousness of adverse (device) events/effects | Seriousness of adverse (device) events/effects | t = 0 - 240 minutes | 
| Relatedness of adverse (device) events/effects | Relatedness of adverse (device) events/effects | t = 0 - 240 minutes | 
| Incidence of device deficiencies of the investigational medical device | Qualitative description of the event, onset, duration, origin, action taken and outcome of the event | t = 0 - 240 minutes | 
| Incidence of protocol deviations related to the investigational medical device | Qualitative description of the event, onset, duration, origin, action taken and outcome of the event | t = 0 - 240 minutes |