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

Prof Dr Jan Tack

Status: Completed

Conditions: Healthy

Treatments: Device: VIPUN Balloon Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03664570

S61853

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

Condition A

Experimental group

Description:

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

Treatment:

Device: VIPUN Balloon Catheter

Condition B

Experimental group

Description:

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

Treatment:

Device: VIPUN Balloon Catheter

Condition C

Experimental group

Description:

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

Treatment:

Device: VIPUN Balloon Catheter