The US Food and Drug Administration (FDA) has approved gastric emptying breath test (GEBT) to aid the diagnosis of gastroparesis.

GEBT measures carbon-13, a naturally existing non-radioactive form of carbon-12, in a patient’s breath. Gastric scintingraphy, the standard diagnostic test for gastroparesis, uses radioactive material and requires specialist training. “[GEBT] can be performed in any clinical setting since it does not require the health care professionals administering the test to undergo special training or to take special precautions related to radiation emitting compounds,” as no radioactive materials are used said Dr. Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

The approval is based on study data of 115 participants who underwent both GEBT and gastric scintigraphy. Performed over a 4-hour period following an overnight fast, GEBT measured the ratio of carbon-13 to carbon-12 in breath samples at multiple points, which is then compared to the baseline measure. Participants consumed a carbon-13 enriched meal containing scrambled egg-mix and Spirulina platensis. GEBT and scintigraphy results agreed 73-97 percent of the time.

Gastroparesis interferes with normal digestion causing severe nausea and vomiting, dehydration, and malnutrition. Diabetes is the most common cause of gastroparesis. Other causes include infections, internal surgery, neurological disease like Parkinson’s disease, and endocrine disorders like hypothyroidism.

GEBT is not advisable for patients with an allergy to Spirulina, egg, milk or wheat, or certain lung diseases or conditions that cause small bowel malabsorption.