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

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.

Study Overview

• Status: Terminated
• Conditions: Gastric Motility
• Intervention / Treatment: Device: VIPUN GMS; Drug: Erythromycin Lactobionate

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: VIPUN GMS; Single arm study.

Device: VIPUN GMS; Motility is measured for 4 hours with the VIPUN Gastric Monitoring System (GMS).; Drug: Erythromycin Lactobionate; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prof Dr Jan Tack

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 7, 2019
• Primary Completion (ACTUAL): March 10, 2020
• Study Completion (ACTUAL): March 10, 2020

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (ACTUAL): August 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Erythromycin lactobionate
• Other Study ID Numbers: S62862

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No