FDA approves breath test to help diagnose gastroparesis

Gastroparesis, or delayed gastric emptying, is a disorder in which the movement of food from the stomach to the small intestine is slowed due to improper muscle contraction. It is caused by damage to the vagus nerve, which controls muscles of the stomach and small intestine. If left untreated, gastroparesis can lead to dehydration, difficulty managing blood glucose in people with diabetes, and malnutrition.

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The Gastric Emptying Breath Test (GEBT) (Advanced Breath Diagnostics) is a new, non-invasive test used to help diagnose gastroparesis. Current tests used in the diagnosis typically involve the use of a small amount of radioactive material or particular imaging equipment, which restricts their use to specialized outpatient centers. The GEBT does not use radioactive material and does not require specialized training for healthcare professionals and therefore can be used in a broader range of settings.

“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 FDA’s Center for Devices and Radiological Health. “It can be performed in any clinical setting since it does not require the healthcare professionals administering the test to undergo special training or to take special precautions related to radiation emitting compounds.” 

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The GEBT is conducted over a 4-hour period following an overnight fast. A baseline breath test is done at the beginning of the test, and then the patient eats a test meal, which includes a scrambled egg-mix and Spirulina platensis, a protein enriched with carbon-13. Carbon-13 is a naturally existing, non-radioactive form of the element carbon-12, both of which are normally found in a patient’s exhaled breath. The GEBT measures the ratio of carbon-13 to carbon-12 in the patient’s breath sample multiple times after the meal is consumed and these levels are compared to baseline to determine how fast the stomach empties the meal into the small intestine.'

The safety and effectiveness of the GEBT was determined in a clinical study involving 115 participants who underwent both the GEBT as well as gastric scintigraphy, which is the current standard of care for the diagnosis of gastroparesis and requires the ingestion of radioactive material. Results showed that the GEBT results matched the scintigraphy results 73% to 97% of the time.

No deaths or serious adverse events were reported during the study. People with hypersensitivity to Spirulina platensis, egg, milk, or wheat allergens, as well as patients with certain lung disease or conditions that cause small bowel malabsorption should avoid the GEBT. 

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