Clinical trial NCT04066231: ANTERO-4: VIPUN Gastric Monitoring System in an Erythromycin Model
Official title: ANTERO-4: A Clinical Investigation of the Effects of Erythromycin on Gastric Motility, Assessed With the VIPUN Gastric Monitoring System in Healthy Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastric Motility
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A gastroprokinetic agent is administered to stimulate gastric motility.
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: GBMI baseline
timeFrame: t = 0 - 119 minutes
measure: GBMI120 - 139
timeFrame: t = 120 - 139 minutes
Secondary outcomes:
measure: GBMI140-240
timeFrame: t = 140 - 240 minutes
measure: Symptoms
timeFrame: t = 0 - 240 minutes
measure: Incidence of adverse events
timeFrame: t = 0 - 240 minutes
measure: Severity of adverse (device) events/effects
timeFrame: t = 0 - 240 minutes
measure: Seriousness of adverse (device) events/effects
timeFrame: t = 0 - 240 minutes
measure: Relatedness of adverse (device) events/effects
timeFrame: t = 0 - 240 minutes
measure: Incidence of device deficiencies of the investigational medical device
timeFrame: t = 0 - 240 minutes
measure: Incidence of protocol deviations related to the investigational medical device
timeFrame: t = 0 - 240 minutes
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
citation: Goelen N, Tack J, Janssen P. Erythromycin stimulates phasic gastric contractility as assessed with an isovolumetric intragastric balloon pressure measurement. Neurogastroenterol Motil. 2021 Feb;33(2):e13991. doi: 10.1111/nmo.13991. Epub 2020 Oct 6.