FDA: The U.S. Food and Drug Administration today approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.
Current tests used to diagnose gastroparesis typically involve the
use of a small amount of radioactive material or imaging equipment, so
testing must be conducted in specialized outpatient centers. The GEBT
can be used in broader settings.
“The GEBT is another option for aiding in the diagnosis of
gastroparesis,” said Alberto Gutierrez, Ph.D., director of the Office of
In Vitro Diagnostics and Radiological Health in the FDA’s Center for
Devices and Radiological Health. “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 when muscles in the stomach are
not contracting properly. It is caused by damage to the vagus nerve that
controls the muscles of the stomach and small intestine, often as a
result of intestinal surgery, neurological diseases such as Parkinson’s
disease and multiple sclerosis, or high blood glucose levels due to
diabetes. If 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.
The GEBT, conducted over a four-hour period after an overnight fast,
is designed to show how fast the stomach empties solids by measuring
carbon dioxide in a patient’s breath. Patients have baseline breath
tests conducted at the beginning of the test. They then eat a special
test meal that includes a scrambled egg-mix and Spirulina platensis, a
type of protein that has been enriched with carbon-13, which can be
measured in breath samples.
Carbon-13 is a naturally existing non-radioactive form of the common
element carbon-12. Both carbon-12 and a very small amount of carbon-13
are normally found in exhaled carbon dioxide. 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.
To support the safety and effectiveness of the GEBT, researchers
conducted a clinical study using data from 115 participants who would
typically undergo a gastric emptying test. All participants underwent
testing with both the GEBT and gastric scintigraphy, the standard of
care for measuring gastric emptying that requires ingestion of a test
meal containing a radioactive material. Researchers compared diagnostic
results from both the GEBT and scintigraphy and found that GEBT results
agreed with scintigraphy results 73-97 percent of the time when measured
at various time points during the test.
No deaths or serious adverse events occurred during clinical studies.
Some study 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.
The GEBT is manufactured by Advanced Breath Diagnostics, based in Brentwood, Tenn.
The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation’s food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.