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New Intestinal Permeability Test Kit Approved

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.

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.

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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.

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5 Responses:

 
Jeanne Coppola
Rating: ratingfullratingfullratingfullratingfullratingempty Unrated
said this on
23 Jan 2010 6:30:47 PM PDT
Very good...this article explained a lot about intestinal permeability, and its consequences. Especially infections. But it needed more information about the test kit and how much it costs.

 
Roland Berger
Rating: ratingfullratingfullratingfullratingfullratingempty Unrated
said this on
11 Aug 2011 2:28:44 PM PDT
Very good...this article explained a lot about intestinal permeability, and its consequences. Especially infections. But it needed more information about the test kit and how much it costs.

 
Zoe
Rating: ratingfullratingemptyratingemptyratingemptyratingempty Unrated
said this on
21 Feb 2013 7:01:53 PM PDT
Needed details of how to order and cost.

 
Sally
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said this on
17 May 2015 1:35:43 PM PDT
How do you order the test? How much does it cost? Basic information that should have been included in the article!

 
DM Mouton
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said this on
23 Aug 2016 4:50:20 AM PDT
In South Africa many people including doctors and specialists do not accept the existence of celiac disease and even some learned professionals declared it as " the bored housewife syndrome." Sadly this is not helping people like me and many others who know we are not hypochondriac. Thank you so much for the information and hope that your articles bring.




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http://www.cureceliacdisease.org/faqs/ You can also find lots of information on celiac at the University of Chicago celiac site. One test they suggest is the anti EMA antibodies. I don't see that one listed in her results. Probably because it is more expensive to do. So they may have skipped it. The other test they usually do is the total serum IGA levels, which is used to prove that the person's immune system actually makes IgA antibodies. some people don't make IgA antibodies, so the IgA tests are useless in them. It looks to me like she makes IgA though, if this is the serum IgA result. IgA 133 mg/dl Reference range 33-200 There are also gene tests they can do. The genes indicate the possibility of developing celiac disease, not the automatic presence of celiac disease. About 30% of people in the USA have one of the genes for celiac disease, but only about 1% develop celiac disease. Some of the celiac genes are associated with other autoimmune conditions besides celiac disease. So there are lists of AI associated conditions with celiac disease. Sometimes called related conditions. http://www.drschaer-institute.com/us/celiac-disease/associated-conditions-1051.html

Blood was drawn this afternoon... they said I could get results tomorrow or even the next day! I also have a GI appt scheduled for June 9th. I am so glad I will have at least some kind of answer pretty soon. I'll let you all know. Thanks again for being so helpful!

Thank you so much for those links, I will check into it. Her pediatrician told me this afternoon she is wanting to repeat the bloodwork since that one test was elevated. I'm relieved that her pediatrician didn't dismiss it like the other dr in the practice did.

http://www.houstonceliacs.org/ https://www.csaceliacs.org/csa_chapter_25.jsp You can check with these groups to see if they recommend any doctors in Houston.

I have been having issues with gluten for quite some time now and decided to go gluten free back in October, I finally got the celiac blood test a couple weeks ago and it came back inconclusive. My doctor referred me to a gastroenterologist who I saw today, she told me I'd have to eat gluten rich foods for 1 month and then have another blood test done....of it comes back negative she said I'd need to eat gluten another few weeks (up to another month) and then do a scope and biopsy....this would be hell on me as I have severe cramping and nausea when I am exposed to gluten. I haven't actually eaten anything that is straight gluten like bread so I'm not sure what would happen. She gave me the option to hold off and continue my diet or go through 2 months of pure gluten exposure (and pain) my question is has anyone been faced with this? Should I just continue with my gluten free diet and assume I have it or is the diagnosis really that important? Doc says based on my symptoms and reactions I more than likely have it.