Delayed Gastric Emptying13CNCT02397577
Reference Values for Gastric Emptying
A study testing Solid test meal, liquid test meal on two separate occations in people with Delayed Gastric Emptying, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delayed Gastric Emptying
- What is being tested?
- Solid test meal, liquid test meal on two separate occations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects free of relevant abdominal complaints
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Gastroenterology, University Hospital Zurich
Zurich, 8091
About this study
Official title: 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.
Read the 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.
- Conditions
- Delayed Gastric Emptying
- Being tested
- Solid test meal, liquid test meal on two separate occations
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solid test meal, liquid test meal on two separate occationsOther
13C labeld solid test meal, 13C labeld liquid test meal on two separate occations
| Study group | Role | What they receive |
|---|---|---|
| gastric emptying measurements | Other | Not described Receives: Other: Solid test meal, liquid test meal on two separate occations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)
Measured: 4 hours after test meal
Secondary outcomes (3)
t50 according to Bluck & Coward (t50_Bluck)
Measured: 4 hours after test meal
t50 according to Wagner & Nelson (t50_WN)
Measured: 4 hours after test meal
Gastric emptying coefficient (GEC)
Measured: 4 hours after test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Gastric EmptyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397577
- Sponsor's protocol ID
- KEK-ZH-NR. 2013-0338
- Acronym
- 13C
- Status last verified
- Jul 2018
- First submitted
- 18 Mar 2015
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Values for Gastric Emptying in a 13C-octanoate Breath Test Using a Solid Test Meal
- ClinicalTrials.gov ID
- NCT02397577
- Acronym / sponsor ID
- 13C / KEK-ZH-NR. 2013-0338
- Conditions
- Delayed Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- Feb 2015 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastric emptying measurements | Other | Other: Solid test meal, liquid test meal on two separate occations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects free of relevant abdominal complaints
- Written informed consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solid test meal, liquid test meal on two separate occations13C labeld solid test meal, 13C labeld liquid test meal on two separate occations | Other | gastric emptying measurements |
Primary outcome
Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)
Time frame: 4 hours after test meal
3 secondary outcomes
t50 according to Bluck & Coward (t50_Bluck)
Time frame: 4 hours after test meal
t50 according to Wagner & Nelson (t50_WN)
Time frame: 4 hours after test meal
Gastric emptying coefficient (GEC)
Time frame: 4 hours after test meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solid test meal, liquid test meal on two separate occations in people with Delayed Gastric Emptying, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos) (time frame: 4 hours after test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018; AzTrials last refreshed its copy on 30 Oct 2026.