Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

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.
    

Detailed description: 
      The objective of this study is to compare gastric emptying assessed by the modified 13C
      spirulina breath test and scintigraphy in 30 subjects, i.e., 15 healthy subjects and 15 with
      dyspepsia. Gastric emptying will be simultaneously assessed by both methods using a
      dual-labeled meal. It is anticipated that the gastric emptying half-time (t½) values based on
      the 13C breath excretion values will compare with the gold standard, scintigraphy, in which
      the "true" t½ values are obtained. The aims of this study are to estimate factors necessary
      for converting exhaled 13C concentrations to gastric emptying half-time, as measured by
      scintigraphy, in healthy subjects and patients with dyspepsia.

      For each potential participant, a screening visit will be conducted within 4 weeks prior to
      the study visit. During the screening visit, informed consent will be obtained, and a
      physical exam will be conducted by a trained investigator. Participants will then be free to
      leave the test site. A urine pregnancy test for women of child-bearing potential will be
      completed within 48 hours prior to exposure to radiation. After an overnight (minimum 8 hour)
      fast, the participants will return to the study center, at which time the dual-label Gastric
      Emptying Test will be administered. A baseline breath sample will be collected in duplicate
      by having the subject blow through a straw into a collection tube. The test meal will be
      prepared by personnel at the test site after the subject arrives. Step-by-step test meal
      preparation instructions are provided with the GEBT kit. The patient will consume the test
      meal containing [13C]-Spirulina and 99mTc sulfur colloid in no more than 10 minutes.
      Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30,
      45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at
      baseline before the test meal is started and thereafter on the same time schedule as the
      scintigraphic procedure.

      As the cooked egg is triturated by the stomach, it passes through the pylorus into the
      intestine where the [13C]-Spirulina platensis is digested, absorbed, and metabolized giving
      rise to labeled carbon dioxide expired in the breath. Breath samples, collected before and
      after the test meal, are shipped overnight to Advanced Breath Diagnostics for analysis by Gas
      Isotope Ratio Mass Spectroscopy. By measuring the change in excretion over time, the rate of
      gastric emptying can be determined.
    

Intervention name(s): [13C]-Spirulina platensis and 99mTc sulfur colloid
Intervention type(s): Drug
Intervention description(s): The subject will consume the test meal containing 13C-Spirulina and 99mTc sulfur colloid in no more than 10 minutes. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Breath test; Dyspepsia; Gastric Emptying; Gastroparesis