Enteral Nutrition Infusion Rate and Gastric Function

NCT03664570 | Completed

• 1 other identifier: S61853
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Gastric motility

Outcome Measures

Primary Outcomes (3)

• Motility

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

  8 hour

• Gastric emptying rate (13C-Octanoate Breath Test)

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

  8 hour

• Gastric emptying rate (Magnetic resonance imaging)

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

  Conditions B and C: 4 hour.

Secondary Outcomes (6)

• Satiation

  6 hour

• Safety profile VIPUN Balloon Catheter

  Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks

• Feasibility VIPUN Balloon Catheter related procedures

  Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks

• 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).

• Position catheter at t=480.

  During Condition A only: at t=480 minutes (after cessation motility recording).

Study Arms (3)

Condition A

EXPERIMENTAL

* Infusion rate = 25 ml/h * Radiography: confirmation balloon position * VIPUN Balloon Catheter * 13C-Octanoate Breath Test o

Device: VIPUN Balloon Catheter

Condition B

EXPERIMENTAL

* Infusion rate = 75 ml/h * Magnetic resonance imaging * VIPUN Balloon Catheter * 13C-Octanoate Breath Test

Device: VIPUN Balloon Catheter

Condition C

EXPERIMENTAL

* Infusion rate = 250 ml/h * Magnetic resonance imaging * VIPUN Balloon Catheter * 13C-Octanoate Breath Testt

Device: VIPUN Balloon Catheter

Interventions

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.

Also known as: VIPUN system

Condition A; Condition B; Condition C

Eligibility Criteria

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

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Prof Dr Jan Tack: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Design

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

Model Details: Three-way crossover

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 10, 2018
• Study Start: October 3, 2018
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)