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

• Status: Terminated
• Trial end date: 2020-03-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Prof Dr Jan Tack
• Treatments: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin lactobionate; Erythromycin stearate

Criteria

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