Clinical Trials Directory

Trials / Completed

CompletedNCT03664570

Enteral Nutrition Infusion Rate and Gastric Function

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Prof Dr Jan Tack · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DEVICEVIPUN Balloon CatheterThe 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.

Timeline

Start date
2018-10-03
Primary completion
2019-04-05
Completion
2019-04-05
First posted
2018-09-10
Last updated
2019-04-24

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03664570. Inclusion in this directory is not an endorsement.