Breath Test Aids Diagnosis of Delayed Gastric Emptying

Patients have baseline breath tests at the beginning of the four-hour test; they then eat a test meal that includes a scrambled egg-mix and Spirulina platensis, a protein enriched with carbon-13, a naturally existing non-radioactive form of carbon-12 which can be measured in breath samples. Both carbon-12 and a very small amount of carbon-13 are normally found in exhaled CO2.

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. Clinical data from 115 participants who underwent a gastric emptying test with both the GEBT and gastric scintigraphy (the standard of care for measuring gastric emptying) showed a 73%–97% match between the test results, depending when measured during the test. The GEBT is manufactured by Advanced Breath Diagnostics (Brentwood, TN, USA), and has been approved by the US Food and Drug Administration (FDA; Silver Spring, MD, USA).

“The GEBT is another option for aiding in the diagnosis of gastroparesis,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health (CADR). “It 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.”

Gastroparesis is a disorder that slows or stops the movement of food from the stomach to the small intestine due to damage to the vagus nerve, causing improper contraction of the muscles of the stomach and small intestine. It is often the result of intestinal surgery, neurological diseases such as Parkinson’s disease and multiple sclerosis (MS), or high blood glucose levels due to diabetes. If left untreated, gastroparesis can lead to severe dehydration due to persistent vomiting, difficulty managing blood sugar levels in diabetics, and malnutrition due to poor absorption of nutrients or low caloric intake.

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US Food and Drug Administration