A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying (ANTERO-AC-7)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Gastric Emptying; Healthy

Treatments: Diagnostic Test: 13C-octanoate breath test for gastric emptying

Study type: Interventional

Funder types: Other

Identifiers

NCT03410147

S61107

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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4 participants in 3 patient groups

Concentration A

Other group

Description:

Concentration of 13C-sodium octanoate in enteral nutrition is 0.3 mg/ml

Treatment:

Diagnostic Test: 13C-octanoate breath test for gastric emptying

Concentration B

Other group

Description:

Concentration of 13C-sodium octanoate in enteral nutrition is 1.0 mg/ml

Treatment:

Diagnostic Test: 13C-octanoate breath test for gastric emptying

Concentration C

Other group

Description:

Concentration of 13C-sodium octanoate in enteral nutrition is 3.0 mg/ml

Treatment:

Diagnostic Test: 13C-octanoate breath test for gastric emptying