Reference Values for Gastric Emptying (13C)

July 2, 2018 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Division of Gastroenterology, University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: gastric emptying measurements
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)
Time Frame: 4 hours after test meal
4 hours after test meal

Secondary Outcome Measures

Outcome Measure
Time Frame
t50 according to Bluck & Coward (t50_Bluck)
Time Frame: 4 hours after test meal
4 hours after test meal
t50 according to Wagner & Nelson (t50_WN)
Time Frame: 4 hours after test meal
4 hours after test meal
Gastric emptying coefficient (GEC)
Time Frame: 4 hours after test meal
4 hours after test meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-NR. 2013-0338

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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