The U.S. Food and Drug Administration approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test for the treatment of delayed gastric emptying, known as gastroparesis. Gastroparesis is a condition in which your stomach cannot empty itself of food in a normal fashion. It is caused by damage to the vagus nerve, which regulates the digestive system. A damaged vagus nerve prevents the muscles in the stomach and intestine from functioning, preventing food from moving through the digestive system properly. If this left untreated, gastroparesis can lead to problems such as severe dehydration due to persistent vomiting, difficulty managing blood sugar levels in people with diabetes, and malnutrition due to poor absorption of nutrients or a low caloric intake.
GEBT can be performed in any clinical setting. It does not require any special training. It involve the use of a small amount of radioactive material or imaging equipment. the GEBT is conducted over four hours after an overnight fast, and measures carbon dioxide in a patient’s breath to show how fast the stomach empties solids. After a baseline breath test, patients eat a special meal that includes Spirulina platensis enriched with carbon-13, which is then measured in breath samples.
Carbon-13 is a naturally existing non-radioactive form of the common element carbon-12. By adding carbon-13 to the test meal, the GEBT can determine how fast the stomach empties the meal by measuring the ratio of carbon-13 to carbon-12 collected in breath samples at multiple time points after the meal is consumed compared to baseline.
This approval follows positive results from a clinical study involving 115 patients who would typically undergo a gastric emptying test. All patients underwent GEBT and gastric scintigraphy, and the researchers compared results from both modalities. Both results agreed between 73% to 97% of the time at various points. No serious adverse events occurred. Few participants reported nausea and stomach discomfort during the test. People with hypersensitivity to Spirulina, egg, milk or wheat allergens should avoid the GEBT. The test also should not be administered to people with certain lung diseases or conditions that cause small bowel malabsorption.
