Reference Values for Gastric Emptying

Delayed Gastric Emptying Clinical Trial

— 13C  

Official title:

Normal Values for Gastric Emptying in a 13C-octanoate Breath Test Using a Solid Test Meal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397577
• Other study ID #: KEK-ZH-NR. 2013-0338
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: May 1, 2018

Study information

• Verified date: July 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects free of relevant abdominal complaints

• Written informed consent

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

Related Conditions & MeSH terms

• Delayed Gastric Emptying
• Gastroparesis

Intervention

Other:
• Solid test meal, liquid test meal on two separate occations
13C labeld solid test meal, 13C labeld liquid test meal on two separate occations

Locations

Country	Name	City	State
Switzerland	Division of Gastroenterology, University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)		4 hours after test meal
Secondary	t50 according to Bluck & Coward (t50_Bluck)		4 hours after test meal
Secondary	t50 according to Wagner & Nelson (t50_WN)		4 hours after test meal
Secondary	Gastric emptying coefficient (GEC)		4 hours after test meal