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

NCT04066231 | Terminated

• 1 other identifier: S62862
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Motility

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• GBMI140-240

  t = 140 - 240 minutes

• Symptoms

  t = 0 - 240 minutes

• Incidence of adverse events

  t = 0 - 240 minutes

• Severity of adverse (device) events/effects

  t = 0 - 240 minutes

• Seriousness of adverse (device) events/effects

  t = 0 - 240 minutes

Study Arms (1)

VIPUN GMS

EXPERIMENTAL

Single arm study.

Device: VIPUN GMS; Drug: Erythromycin Lactobionate

Interventions

VIPUN GMS DEVICE

Motility is measured for 4 hours with the VIPUN Gastric Monitoring System (GMS).

VIPUN GMS

Erythromycin Lactobionate DRUG

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.

VIPUN GMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof Dr Jan Tack: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 33025716 DERIVED

MeSH Terms

Interventions

erythromycin lactobionate

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Clinic - Gastroenterology / Professor of Medicine / Principal Investigator

Model Details: A gastroprokinetic agent is administered to stimulate gastric motility.

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 26, 2019
• Study Start: September 7, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)