New Test for Delayed Gastric Emptying
Wednesday, August 19, 2015
In a news release issued in early April, the U.S. Food and Drug Administration announced that it had approved the Gastric Emptying Breath Test (GEBT), a new noninvasive test to aid in the diagnosis of delayed gastric emptying, or gastroparesis. Unlike current tests for gastroparesis, this test can be performed in a general clinical setting and does not require radioactive material.
The GEBT shows how fast the stomach empties solids by measuring carbon dioxide in a patient’s breath. It is conducted over a four-hour period after an overnight fast. Patients have baseline breath tests conducted, 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 in breath samples collected 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 results from both the GEBT and scintigraphy and found that GEBT results agreed with scintigraphy results 73 to 97 percent of the time when measured at various time points during the test.
Read the full FDA press release here
LifelineLetter, May/June 2015