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NCT01248221 · ClinicalTrials.gov registry record · NA
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01248221: Completed NA study, sponsored by Mayo Clinic.
NCT01248221 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01248221, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG [13C]-Spirulina platensis and 99mTc sulfur colloid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01248221
The ClinicalTrials.gov registry entry for NCT01248221 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [13C]-Spirulina platensis and 99mTc sulfur colloid is the first listed.
NCT01248221 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01248221 about?
NCT01248221 is a clinical study titled "Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)". 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 label...
What is the current status of trial NCT01248221?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2010-12. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01248221?
The interventions under investigation include: [13C]-Spirulina platensis and 99mTc sulfur colloid (DRUG).
Who is sponsoring clinical trial NCT01248221?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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