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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concentration A | Other | Concentration of 13C-sodium octanoate in enteral nutrition is 0.3 mg/ml |
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| Concentration B | Other | Concentration of 13C-sodium octanoate in enteral nutrition is 1.0 mg/ml |
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| Concentration C | Other | Concentration of 13C-sodium octanoate in enteral nutrition is 3.0 mg/ml |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13C-octanoate breath test for gastric emptying | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hourly 13C-recovery | Indicator for gastric emptying rate | 8 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D005746 | Gastric Emptying |
| ID | Term |
|---|---|
| D005769 | Gastrointestinal Motility |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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A single blind, randomized, crossover monocentric study in a cohort of adult healthy volunteers
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