Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Mayo Clinic
Collaborators:
Advanced Breath Diagnostics, LLC National Center for Research Resources (NCRR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)