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

Prof Dr Jan Tack

Status: Terminated

Conditions: Gastric Motility

Treatments: Device: VIPUN GMS; Drug: Erythromycin Lactobionate

Study type: Interventional

Funder types: Other

Identifiers

NCT04066231

S62862

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

VIPUN GMS

Experimental group

Description:

Single arm study.

Treatment:

Drug: Erythromycin Lactobionate

Device: VIPUN GMS