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Completed

NCT Number: NCT03664570

Enteral Nutrition Infusion Rate and Gastric Function

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VIPUN Balloon Catheter

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Prof Dr Jan Tack

Other

Registry information

Official study 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.

Acronym: ANTERO-3

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2018
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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