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A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT03410147•Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+4 more criteria

Locations (1)

UZ Leuven

Leuven, Belgium

Key Dates

Start Date

February 9, 2018

Primary Completion Date

March 29, 2018

Completion Date

March 29, 2018

Last Updated

July 19, 2018

Enrollment

ACTUAL participants

Conditions

HealthyGastric Emptying

Interventions

13C-octanoate breath test for gastric emptying

DIAGNOSTIC_TEST

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Collection of Data and Samples From Healthy Donors for Use in Translational Research

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