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Reference Values for Gastric Emptying (13C)

Primary Purpose

Delayed Gastric Emptying

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Solid test meal, liquid test meal on two separate occations
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delayed Gastric Emptying

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Division of Gastroenterology, University Hospital Zurich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

gastric emptying measurements

Arm Description

Outcomes

Primary Outcome Measures

Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)

Secondary Outcome Measures

t50 according to Bluck & Coward (t50_Bluck)
t50 according to Wagner & Nelson (t50_WN)
Gastric emptying coefficient (GEC)

Full Information

First Posted
March 18, 2015
Last Updated
July 2, 2018
Sponsor
University of Zurich
Collaborators
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT02397577
Brief Title
Reference Values for Gastric Emptying
Acronym
13C
Official Title
Normal Values for Gastric Emptying in a 13C-octanoate Breath Test Using a Solid Test Meal
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
University of Bern

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Gastric Emptying

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gastric emptying measurements
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Solid test meal, liquid test meal on two separate occations
Intervention Description
13C labeld solid test meal, 13C labeld liquid test meal on two separate occations
Primary Outcome Measure Information:
Title
Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)
Time Frame
4 hours after test meal
Secondary Outcome Measure Information:
Title
t50 according to Bluck & Coward (t50_Bluck)
Time Frame
4 hours after test meal
Title
t50 according to Wagner & Nelson (t50_WN)
Time Frame
4 hours after test meal
Title
Gastric emptying coefficient (GEC)
Time Frame
4 hours after test meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Gastroenterology, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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Reference Values for Gastric Emptying

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