Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
Public ClinicalTrials.gov record NCT01248221. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
[13C]-Spirulina Platensis GEBT - Dual-Label Validation Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia. Subjects will eat a standard meal of 2 scrambled eggs, a slice of wheat toast and 8 ounces of skim milk. The eggs will be double labeled with Technetium-99m (99mTc) sulfur colloid and 13C-Spirulina platensis. Scintigraphy is a diagnostic technique in which a two-dimensional picture of internal body tissue is produced through the detection of radiation emitted by a radioactive substance administered into the body. The location of a standard meal in the digestive system will be measured by images of the 99mTc sulfur colloid taken at periodic intervals before and after the standard meal. The 99mTc Sulfur Colloid is approved by the FDA for use in medical diagnostic procedures. Spirulina platensis is blue - green algae, which is very similar to the naturally occurring spirulina sold in health food stores as a dietary supplement. The spirulina platensis has been labeled with the 13C stable isotope. 13C stable isotope labeling is inherently safe as 1.1% of all carbon in our bodies and in the food we eat is 13C. The presence of the 13C will be measured by breath samples at periodic intervals before and after a standard meal. The FDA considers 13C-Spirulina platensis to be investigational for the purposes of this study.
Study identification
- NCT ID
- NCT01248221
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2010
- Primary completion
- Nov 30, 2011
- Completion
- Nov 30, 2011
- Last update posted
- Mar 17, 2013
2010 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01248221, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 17, 2013 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01248221 live on ClinicalTrials.gov.