Conventional measurements of gastric emptying (1) employ radioactive tracers, (2) require preparation of the liquid and solid phases of the meal immediately before the test, and (3) require a gamma scintillation camera to record the passage of the labeled meal from the stomach. We have developed a breath test kit containing a meal suitable for measurement of gastric emptying in a physician's office. The 340-calorie meal contains 90 g solid phase and 90 g liquid phase, either of which may be labeled with a proprietary 13C tracer. The meal is palatable, as well as stable for at least a week at room temperature and for several months when frozen. Conduct of the measurement requires only that the subject consume the meal and collect five breath samples. Preliminary validation against radioactive measurements indicates excellent correlation and suggests the test can be carried out within 120 minutes. Phase I of this SBIR proposes individual validations against solid and liquid radioactive measures in 10 normal subjects and 30 patients with gastric dumping or paresis. In Phase II, multicenter clinical trials will be carried out to provide the basis for a 51OK submission to the Food and Drug Administration. PROPOSED COMMERCIAL APPLICATION: Development of this noninvasive and nonradioactive 13C test meal will enable a physician to measure gastric emptying without special equipment in an outpatient setting.
Thesaurus Terms:breath test, carbon, diagnosis design /evaluation, stable isotope, stomach emptying clinical trial, nuclear medicine, radiotracer, stable isotope diagnosis clinical research, human subject, mass spectrometryNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
