Reference Values for Gastric Emptying
13C
Normal Values for Gastric Emptying in a 13C-octanoate Breath Test Using a Solid Test Meal
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 18, 2015
CompletedFirst Posted
Study publicly available on registry
March 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedJuly 5, 2018
July 1, 2018
3.2 years
March 18, 2015
July 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)
4 hours after test meal
Secondary Outcomes (3)
t50 according to Bluck & Coward (t50_Bluck)
4 hours after test meal
t50 according to Wagner & Nelson (t50_WN)
4 hours after test meal
Gastric emptying coefficient (GEC)
4 hours after test meal
Study Arms (1)
gastric emptying measurements
OTHERInterventions
13C labeld solid test meal, 13C labeld liquid test meal on two separate occations
Eligibility Criteria
You may qualify if:
- Subjects free of relevant abdominal complaints
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- University of Berncollaborator
Study Sites (1)
Division of Gastroenterology, University Hospital Zurich
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2015
First Posted
March 25, 2015
Study Start
February 1, 2015
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
July 5, 2018
Record last verified: 2018-07