Enteral Nutrition Infusion Rate and Gastric Function (ANTERO-3)

April 23, 2019 updated by: Prof Dr Jan Tack

ANTERO-3: The Impact of Enteral Nutrition Infusion Rate on Gastric Motility and Gastric Emptying Rate, Measured With the VIPUN Balloon Catheter, Magnetic Resonance Imaging and the 13C-octanoate Breath Test.

A complex neurohumoral feedback mechanism regulates gastric emptying of enteral nutrition through changes in gastric motility. In this investigation, we aim to investigate the impact of different infusion rates of enteral nutrition on gastric motility, gastric emptying rate, epigastric symptoms and satiation.

Additionally, magnetic resonance imaging will be used to validate an extended 13C-octanoate breath test for gastric emptying of a liquid test meal that is infused over 2 hours. Furthermore, the reliability of a manual position check of the VIPUN Balloon catheter will be confirmed with radiographic imaging. Finally, the data will be used for the data driven optimization of the VIPUN MI algorithm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed Informed Consent
  • At least 18 years old
  • BMI between and including 18 and 30
  • Understand and able to read Dutch
  • In good health on the basis of medical history
  • Female subjects of childbearing potential are willing to use adequate contraception
  • 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
  • History of thermal or chemical injury to upper respiratory tract or esophagus
  • Current esophageal or nasopharyngeal obstruction
  • Known coagulopathy
  • Known esophageal varices
  • Metal or other MRI incompatible implants
  • Contra-indications for MR (checked by MR safety questionnaire)
  • Pregnancy
  • Claustrophobia
  • Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Isosource Standard.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Condition A
  • Infusion rate = 25 ml/h
  • Radiography: confirmation balloon position
  • VIPUN Balloon Catheter
  • 13C-Octanoate Breath Test o
Device: VIPUN Balloon Catheter
The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.
Other Names:
  • VIPUN system
Experimental: Condition B
  • Infusion rate = 75 ml/h
  • Magnetic resonance imaging
  • VIPUN Balloon Catheter
  • 13C-Octanoate Breath Test
Device: VIPUN Balloon Catheter
The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.
Other Names:
  • VIPUN system
Experimental: Condition C
  • Infusion rate = 250 ml/h
  • Magnetic resonance imaging
  • VIPUN Balloon Catheter
  • 13C-Octanoate Breath Testt
Device: VIPUN Balloon Catheter
The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.
Other Names:
  • VIPUN system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motility
Time Frame: 8 hour
Motility index (MI) measured with the VIPUN Balloon Catheter.
8 hour
Gastric emptying rate (13C-Octanoate Breath Test)
Time Frame: 8 hour
Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test.
8 hour
Gastric emptying rate (Magnetic resonance imaging)
Time Frame: Conditions B and C: 4 hour.
Gastric emptying rate of liquid test meal, measured with magnetic resonance imaging
Conditions B and C: 4 hour.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satiation
Time Frame: 6 hour
Subjective satiation score at a 30-minute interval. Visual Analogue Scale (100 mm, 0=absent, 100= maximal sensation).
6 hour
Safety profile VIPUN Balloon Catheter
Time Frame: Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Incidence, frequency, severity, seriousness and relatedness of AE's
Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Feasibility VIPUN Balloon Catheter related procedures
Time Frame: Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Success rate of completing the procedure (placement and removal VIPUN Balloon Catheter
Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Reliability manual position check
Time Frame: Once for each subject (during Condition A only): Position of the inflated balloon is judged on the thorax Rx (t<0) prior to start motility recording (= reference time point, t=0).
Success rate (pass/fail) (reliability) of the manual position check of the VIPUN balloon catheter
Once for each subject (during Condition A only): Position of the inflated balloon is judged on the thorax Rx (t<0) prior to start motility recording (= reference time point, t=0).
Position catheter at t=480.
Time Frame: During Condition A only: at t=480 minutes (after cessation motility recording).
Qualitative assessment of the migration of the catheter over the course of the study procedures.
During Condition A only: at t=480 minutes (after cessation motility recording).
Epigastric symptoms
Time Frame: 6 hours
Subjective epigastric symptom scores at a 30-minute interval. 3 Visual Analogue Scales (100 mm, 0=absent, 100= maximal sensation). Scale 1: Nausea, Scale 2: Bloating, Scale 3: Pain.
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof Dr Jan Tack

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2018

Primary Completion (Actual)

April 5, 2019

Study Completion (Actual)

April 5, 2019

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S61853

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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