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

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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Key information

Conditions

Healthy Gastric Emptying

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Hourly 13C-recovery

Time frame: 8 hour

Indicator for gastric emptying rate

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: ANTERO-AC-7

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jan 25, 2018
Registry last updated: Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed