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ANTERO-3: Enteral Nutrition Infusion Rate and Gastric Function

Sponsor
Prof Dr Jan Tack (Other)
Overall Status
Completed
CT.gov ID
NCT03664570
Collaborator
(none)
19
Enrollment
1
Location
3
Arms
6
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VIPUN Balloon Catheter
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Three-way crossoverThree-way crossover
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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.
Actual Study Start Date :
Oct 3, 2018
Actual Primary Completion Date :
Apr 5, 2019
Actual Study Completion Date :
Apr 5, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Motility [8 hour]

      Motility index (MI) measured with the VIPUN Balloon Catheter.

    2. Gastric emptying rate (13C-Octanoate Breath Test) [8 hour]

      Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test.

    3. Gastric emptying rate (Magnetic resonance imaging) [Conditions B and C: 4 hour.]

      Gastric emptying rate of liquid test meal, measured with magnetic resonance imaging

    Secondary Outcome Measures

    1. Satiation [6 hour]

      Subjective satiation score at a 30-minute interval. Visual Analogue Scale (100 mm, 0=absent, 100= maximal sensation).

    2. Safety profile VIPUN Balloon Catheter [Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks]

      Incidence, frequency, severity, seriousness and relatedness of AE's

    3. Feasibility VIPUN Balloon Catheter related procedures [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

    4. Reliability manual position check [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

    5. Position catheter at t=480. [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.

    6. Epigastric symptoms [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Vlaams-Brabant Belgium 3000

    Sponsors and Collaborators

    • Prof Dr Jan Tack

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof Dr Jan Tack, Head of Clinic - Gastroenterology / Professor of Medicine / Principal Investigator, Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT03664570
    Other Study ID Numbers:
    • S61853
    First Posted:
    Sep 10, 2018
    Last Update Posted:
    Apr 24, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prof Dr Jan Tack, Head of Clinic - Gastroenterology / Professor of Medicine / Principal Investigator, Universitaire Ziekenhuizen Leuven
    Gastric motility

    Study Results

    No Results Posted as of Apr 24, 2019