This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Gastric Emptying Breath Test (GEBT)
PMA Applicant: Advanced Breath Diagnostics, LLC
Address: 105 Westpark Drive, Suite 150, Brentwood, TN 37027
Approval Date: April 6, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110015a.pdf
What is it? The Gastric Emptying Breath Test (GEBT) measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (gastroparesis). 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 often the result of intestinal surgery, neurological diseases such as Parkinson's disease and multiple sclerosis, or high blood glucose levels due to diabetes.
How does it work? The GEBT is conducted over a four-hour period after an overnight fast. Patients have an initial breath test and then eat a special test meal that includes Spirulina (a nutritional supplement), powdered egg, and saltine crackers. The Spirulina contains a blue-green algae enriched with a nonradioactive material which can be measured in breath tests. After the meal, breath samples are taken at 45, 90, 120, 150, 180, and 240 minutes. The test shows how fast the stomach empties solids by measuring the amount of the nonradioactive material in a patient's breath.
When is it used? The GEBT helps health care professionals diagnose adults who may have gastroparesis. The most common symptoms of gastroparesis are nausea, a feeling of fullness after eating only a small amount of food, and vomiting undigested food—sometimes several hours after a meal. 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 can be performed in any clinical setting because it does not require health care professionals administering the test to undergo special training and it does not need imaging equipment or the use of radioactive materials.
What will it accomplish? Researchers conducted a clinical study using data from 115 participants. All participants underwent testing with both the GEBT and gastric scintigraphy; the standard of care for measuring gastric emptying that requires consuming a test meal containing a radioactive material. Researchers compared the results from both the GEBT and scintigraphy and found that GEBT results agreed with scintigraphy results 73-97 percent of the time when measured from various time points during the test.
GEBT results should be used together with a patient's medical history to diagnose gastroparesis and determine treatment options.
When should it not be used? The GEBT should not be used in people with:
- hypersensitivity to Spirulina egg, milk or wheat allergens.
- certain lung diseases or conditions that cause the small bowel difficulty in absorbing nutrients.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.