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

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

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.

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