NCT03410147

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Gastric Emptying

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	13C-octanoate breath test for gastric emptying	The 13C-octanoate breath test for gastric emptying will be performed to assess gastric emptying rate of a liquid meal that is infused continuously over a period of 8 hour. 13C-labeled sodium octanoate (food adjective) is mixed with liquid nutrients used for enteral feeding. The concentration of 13C-labeled sodium octanoate is according to the randomized treatment order. This mixture is infused at 20 ml/h for 8 hours (hourly dose of 13C-octanoate differs between treatment arms). In order to estimate gastric emptying rate quantitatively throughout the infusion period, the appearance of 13CO2 in the breath, relative to 12CO2, will be monitored by sampling the exhaled breath at a 15 minute interval. The aim is to induce a steady state hourly 13C-recovery. This would allow to implement the prolonged breath test protocol in future clinical investigations.

Timeline

• Start date: 2018-02-09
• Primary completion: 2018-03-29
• Completion: 2018-03-29
• First posted: 2018-01-25
• Last updated: 2018-07-19

Locations

1 site across 1 country: Belgium