Enteral Nutrition Infusion Rate and Gastric Function

Healthy Clinical Trial

— ANTERO-3  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664570
• Other study ID #: S61853
• Status: Completed
• Phase: N/A
• Start date: October 3, 2018
• Est. completion date: April 5, 2019

Study information

• Verified date: April 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Prof Dr Jan Tack

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motility	Motility index (MI) measured with the VIPUN Balloon Catheter.	8 hour
Primary	Gastric emptying rate (13C-Octanoate Breath Test)	Gastric emptying rate of liquid test meal, measured with 13C-Octanoate Breath Test.	8 hour
Primary	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	Satiation	Subjective satiation score at a 30-minute interval. Visual Analogue Scale (100 mm, 0=absent, 100= maximal sensation).	6 hour
Secondary	Safety profile VIPUN Balloon Catheter	Incidence, frequency, severity, seriousness and relatedness of AE's	Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Secondary	Feasibility VIPUN Balloon Catheter related procedures	Success rate of completing the procedure (placement and removal VIPUN Balloon Catheter	Trough study completion, from Visit 1 until completion of Visit 3, on average 3 weeks
Secondary	Reliability manual position check	Success rate (pass/fail) (reliability) of the manual position check of the VIPUN balloon catheter	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).
Secondary	Position catheter at t=480.	Qualitative assessment of the migration of the catheter over the course of the study procedures.	During Condition A only: at t=480 minutes (after cessation motility recording).
Secondary	Epigastric symptoms	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.	6 hours