Reference Values for Gastric Emptying

Not Applicable

Completed

• Conditions: Delayed Gastric Emptying
• Interventions: Other: Solid test meal, liquid test meal on two separate occations

• Registration Number: NCT02397577
• Lead Sponsor: University of Zurich

Brief Summary

Healthy volunteers will ingest a 13C-octaoate containing test meal and 13C in expiratory air will be followed. Normal values will be calculated data of these tests.

Detailed Description

This is a clinical study for establishing reference values in a 13C-octanoate breath test and a 13C-sodium acetate breath test. Healthy volunteers (n=75) will eat a solid test meal of scrambled eggs and toast containing 13C-octanoate. 13C-content of exhaled air will be measured at baseline and followed for the next 4 hours. One week later, the healthy volunteers (n=75) will drink a standardized nutritional shake (Ensure Plus Vanille, Abbott) containing 13C-sodium acetate. 13C-content of exhaled air will be measured at baseline and for the next 4 hours. Estimated gastric emptying time will be calculated using established algorithms.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-25
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Subjects free of relevant abdominal complaints
• Written informed consent

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Exclusion Criteria

• Age under 18
• Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders)
• Known diabetes mellitus, scleroderma, neurological impairment or other major current disease
• Subjects unable to stop medication that alters gut function for 1 week prior to the study, including anticholinergics, calcium canal inhibitors, beta blocker, prokinetics, proton-pump inhibitors, DDV-IV-Inhibitors, Inkretin-mimetica, non-steroidal anti-inflammatory drugs, macrolid antibiotics
• Pregnancy beyond week 12 (no pregnancy test will be performed)
• Involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion
• Known allergy or intolerance against hen egg protein or gluten

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gastric emptying measurements	Solid test meal, liquid test meal on two separate occations	-

Primary Outcome Measures

Name	Time	Method
Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)	4 hours after test meal

Secondary Outcome Measures

Name	Time	Method
Gastric emptying coefficient (GEC)	4 hours after test meal
t50 according to Bluck & Coward (t50_Bluck)	4 hours after test meal
t50 according to Wagner & Nelson (t50_WN)	4 hours after test meal

Trial Locations

Locations (1)

Division of Gastroenterology, University Hospital Zurich; 🇨🇭 Zurich, Switzerland