Great Smokies Diagnostic Laboratory (GSDL), a private, rapid-growth Functional Medicine Clinical laboratory, announced today receipt of 510(K) market clearance from the Food and Drug Administration (FDA) for its Intestinal Permeability test kit, utilizing the lactulose-mannitol challenge drink. Used in the non-invasive assessment of intestinal permeability, the test demonstrated its superior sensitivity as compared to the existing d-xylose test in measuring intestinal permeability, a measurement used in the diagnosis of gastrointestinal malabsorption syndromes, such as celiac disease, colitis, Crohns disease, and Irritable Bowel Syndrome.
Intestinal permeability refers to impairment of the intestinal mucosal barrier, which is central to healthy absorption of nutrients and protection against bacterial and toxin translocation from the gastrointestinal (GI) tract to the blood stream. Disturbances in mucosal barrier function can lead to malnourishment and increased permeability (leaky gut) which can cause or contribute to disease conditions throughout the body as diverse as asthma, arthritis, and food allergies.
What are gastrointestinal malabsorption syndromes?
Although the Centers for Disease Control (celiac disease) has not gathered statistics specifically for malabsorption itself, tens of millions of Americans suffer from related gut mucosal integrity conditions responsible for enormous healthcare expense. Arthritis, for example, strikes over 43 million annually at a cost of more than $65 million (celiac disease), while functional gastrointestinal disorders are responsible for an estimated 2.5 to 3.5 million visits to doctors every year and some $40 million in medication expenditures (University of North Carolina Functional Gastrointestinal Disorders Center). The incidence of these health disorders and other intestinal permeability related- conditions continues to grow at an alarming rate.
The growing use of non-steroidal anti-inflammatory drugs (NSAIDS), which can irritate the mucosal lining, has contributed significantly to an increase intestinal permeability worldwide. Intestinal Permeability Assessment can be used to monitor treatment of NSAID-related damage to the mucosal barrier and intestinal permeability-related to other irritants in the GI tract. An estimated 20% or more of patients taking NSAIDS develop systematic or endoscopic gastrointestinal toxicity with incidence increasing among the elderly, who account for 40-60% of NSAID users (Canadian Medical Association Journal 1996; 155: 77-88).
Inflammatory and detoxification disorders, impaired healing following surgery, failure to thrive, and complications from radiation and chemotherapy for cancer have all been linked to intestinal permeability. Recent research has consistently underscored the value of Intestinal Permeability Assessment in GI disorders such as Crohns and Irritable Bowel Syndrome, as well as traumatic care, geriatric interventions, adjunctive AIDS therapy, and pediatric care, especially in the treatment of allergies and immune disorders.
GSDL is the first commercial laboratory to offer Intestinal permeability testing. Utilizing state-of-the art technology, GSDL has developed a comprehensive range of functional assessments in the areas of gastroenterology, endocrinology, cardiology, nutrition/metabolism, and immunology. The laboratory conducts aggressive, ongoing research and development for innovative functional assessments.