A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying

Not Applicable

Completed

• Conditions: Healthy; Gastric Emptying
• Interventions: Diagnostic Test: 13C-octanoate breath test for gastric emptying

• Registration Number: NCT03410147
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The objective of this dose-finding and feasibility study is to establish the optimal 13C-octanoate concentration to be used with slowly infused enteral nutrition to perform a prolonged gastric emptying test using the breath test. More specifically, the aim is to discover the 13C-octanoate concentration that induces a steady state hourly 13C-recovery. This would allow to implement the prolonged breath test protocol in a future clinical investigation in critically ill patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-25
• Study Start: 2018-02-09
• Primary Completion: 2018-03-29
• Study Completion: 2018-03-29
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Signed Informed Consent
• At least 18 years old
• BMI between and including 18 and 29
• Understand and able to read Dutch
• In good health on the basis of medical history
• Refrains from herbal, vitamin and other dietary supplements on the day of the visits

Exclusion Criteria

• Dyspeptic symptoms (assessed with PAGI-SYM questionnaire, Annex II)
• 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
• Suspected basal skull fracture or severe maxillofacial trauma
• History of thermal or chemical injury to upper respiratory tract or esophagus
• Current esophageal or nasopharyngeal obstruction
• Known coagulopathy
• Known esophageal varices
• Have a known allergy or intolerance to cow milk, soy or any other ingredient of Isosource Standard.
• Known galactosaemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Concentration A	13C-octanoate breath test for gastric emptying	Concentration of 13C-sodium octanoate in enteral nutrition is 0.3 mg/ml
Concentration B	13C-octanoate breath test for gastric emptying	Concentration of 13C-sodium octanoate in enteral nutrition is 1.0 mg/ml
Concentration C	13C-octanoate breath test for gastric emptying	Concentration of 13C-sodium octanoate in enteral nutrition is 3.0 mg/ml

Primary Outcome Measures

Name	Time	Method
Hourly 13C-recovery	8 hour	Indicator for gastric emptying rate

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium