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Completed

NCT Number: NCT02397577

Reference Values for Gastric Emptying

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Gastroenterology, University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solid test meal, liquid test meal on two separate occations

Other

13C labeld solid test meal, 13C labeld liquid test meal on two separate occations

Primary outcomes

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

    Time frame: 4 hours after test meal

Secondary outcomes

  1. t50 according to Bluck & Coward (t50_Bluck)

    Time frame: 4 hours after test meal

  2. t50 according to Wagner & Nelson (t50_WN)

    Time frame: 4 hours after test meal

  3. Gastric emptying coefficient (GEC)

    Time frame: 4 hours after test meal

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • University of Bern

Registry information

Official study title

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

Acronym: 13C

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2015
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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