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Since this topic and the Great Smokies Diagnostic Lab have been mentioned

lately, I thought some of you might be interested in this.

DATE: July 15, 1999

SPECIAL ANNOUNCEMENT

(Great Smokies is issuing the following news release for general

distribution.)

FDA CLEARS INTESTINAL PERMEABILITY TEST KIT

Asheville, N.C.: 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, Crohn's disease, and Irritable Bowel

Syndrome.

What is intestinal permeability?

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 (CDC) 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

(CDC), 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 Crohn's

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.

###################################################

NOTICE

Great Smokies Diagnostic Laboratory provides this information as a

service to subscribers. This information is for sole use of a

licensed healthcare practitioner and is for educational purposes

only. It is not meant for use as diagnostic information, and reports

of research findings should in no way be construed as treatment

recommendations. Linking to other sites does not constitute an

endorsement of products or services.

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