FAQs

FAQs

FAQs

WHAT IS GASTROPARESIS?

Gastroparesis is a disorder that slows or stops the movement of food from the stomach to the small intestine. Diabetic, postsurgical and idiopathic (unknown) etiologies comprise the majority of cases. Gastroparesis also occurs in post viral patients, patients with refractory symptoms of GERD, functional dyspepsia, neurological disorders such as Parkinson disease and with administration of some pharmacologic agents such as narcotic pain relievers.

WHAT IS GEBT?

The Gastric Emptying Breath Test (GEBT) measures how fast a standardized test meal is emptied from the stomach into the small intestine. Measuring the rate of solid phase gastric emptying is an important aid in the diagnosis of delayed emptying (gastroparesis).

HOW DOES GEBT WORK?

The GEBT is conducted over a four-hour period after an overnight fast. Patients provide fasting pre-meal breath samples and then eat a special test meal containing Spirulina (an alga based nutritional supplement), egg, and saltine crackers. The Spirulina in the GEBT test meal is a pharmaceutical grade, blue-green alga enriched with a safe, non-radioactive form of carbon, carbon-13, denoted as 13C. Carbon-13, in the form of carbon-13 carbon dioxide (13CO2), can be measured in breath samples. After consuming the 13C-labeled test meal, breath samples are collected at 45, 90, 120, 150, 180, and 240 minutes. The test shows how fast the stomach empties by measuring the rate of 13CO2 excretion in a patient’s breath, which is proportional to rate of gastric emptying.

WHEN IS GEBT USED?

The GEBT helps health care professionals evaluate and diagnose patients who are symptomatic for gastroparesis. GEBT is approved for use in patients 18 years and older. The most common symptoms associated with gastroparesis include nausea, vomiting, feelings of fullness after consuming even small amounts of food, bloating and upper abdominal pain. 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 low caloric intake and poor absorption of nutrients.

The GEBT can be performed in any clinical setting because it does not require healthcare professionals administering the test to undergo special training in radiation safety or nuclear medicine imaging techniques that use radioactive materials.

WHEN SHOULD GEBT NOT BE USED?

People with hypersensitivity to Spirulina, egg, milk or wheat allergens should avoid the GEBT.  The GEBT should not be administered to people with certain lung diseases or conditions that cause small bowel malabsorption. For additional warnings and precautions please see the GEBT product labeling.

HOW WAS GEBT VALIDATED AND APPROVED FOR USE IN HUMAN SUBJECTS?

Researchers conducted an FDA-approved safety and effectiveness study at the Mayo Clinic using data from 115 participants representing the intended use population. Each subject underwent simultaneous evaluation by GEBT and Gastric Scintigraphy (GS). GEBT was validated against the method of GS because GS has been considered in the medical community to be the gold standard for diagnosing gastroparesis. GS requires consuming a test meal containing a radioactive material. Researchers compared the results from both the GEBT and GS and found that GEBT results agreed with scintigraphy results 73-97 percent of the time when measured at various time points during the test procedure. GEBT results should be used together with a patient’s medical history to diagnose gastroparesis and determine treatment options. The GEBT is a Class III PMA-approved medical device (combination product) regulated by the United States Food and Drug Administration.

IS THERE CONSENSUS ON USE OF GEBT IN ROUTINE CLINICAL PRACTICE?

Yes. GEBT is described as appropriate for use in clinical practice and as an alternative to Gastric Scintigraphy in the Expert Consensus Document titled “Advances in the diagnosis and classification of gastric and intestinal motility disorders”, Keller, et al, International Working Group for Disorders of Gastrointestinal Motility and Function, May 2018. Appropriateness of use in clinical practice, as cited  in the Expert Consensus Document, is based on (1) Spirulina-GEBT’s high concordance with scintigraphic data, (2) FDA’s approval of the test in April 2015 for the evaluation of gastric emptying, (3) an exactly defined test protocol and (4) validation in a large group of healthy volunteers and patients.”

IS THERE FDA GUIDANCE ON USE OF GEBT IN CLINICAL STUDIES?

Yes. Guidance for use of GEBT in clinical studies evaluating drugs for gastroparesis is published in FDA Guidance “Gastroparesis: Clinical Evaluation of Drugs for Treatment, Guidance for Industry”, July 2015. Although Gastric Scintigraphy (GS) has been considered in the medical community to be the gold standard for diagnosing gastroparesis, FDA notes that “qualified personnel are needed to conduct this test, and scintigraphy induces a significant radiation burden (Siegel, Wu, et al. 1983), which may limit its application in children, fertile women, and subjects undergoing repetitive measurements of gastric emptying in a short period of time. The advantages and disadvantages of each approach (GS or GEBT) should be considered when designing a clinical trial in gastroparesis and when identifying the appropriate patient population for study.”