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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03664570
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven

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
Healthy Device: VIPUN Balloon Catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Three-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 : October 3, 2018
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

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 Name: 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 Name: 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 Name: VIPUN system




Primary Outcome Measures :
  1. Motility [ Time Frame: 8 hour ]
    Motility index (MI) measured with the VIPUN Balloon Catheter.

  2. Gastric emptying rate (13C-Octanoate Breath Test) [ Time Frame: 8 hour ]
    Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test.

  3. 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


Secondary Outcome Measures :
  1. Satiation [ Time Frame: 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 [ 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

  3. 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

  4. 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

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664570


Locations
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Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Prof Dr Jan Tack

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Responsible Party: Prof Dr Jan Tack, Head of Clinic - Gastroenterology / Professor of Medicine / Principal Investigator, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03664570     History of Changes
Other Study ID Numbers: S61853
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Universitaire Ziekenhuizen Leuven:
Gastric motility