Status:
COMPLETED
A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Healthy
Gastric Emptying
Eligibility:
All Genders
18+ years
Phase:
NA
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 emptyin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2018
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03410147
Start Date
February 9 2018
End Date
March 29 2018
Last Update
July 19 2018
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000