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  • Scott Adams
    Scott Adams

    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.

    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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    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.

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    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.

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    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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  • About Me

    In 1994 I was diagnosed with celiac disease, which led me to create Celiac.com in 1995. I created this site for a single purpose: To help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives. Celiac.com was the first site on the Internet dedicated solely to celiac disease. In 1998 I founded The Gluten-Free Mall, Your Special Diet Superstore!, and I am the co-author of the book Cereal Killers, and founder and publisher of Journal of Gluten Sensitivity.

  • Related Articles

    Jefferson Adams
    Celiac.com 10/12/2007 - A team of Dutch dentists recently conducted a study to determine if Dutch children with proven celiac disease exhibit corresponding defects in dental enamel and to gauge whether children without proven celiac disease, but showing celiac-associated gastro-intestinal complaints lack any such defects in their dental enamel.
    The research team included CLAAR D. WIERINK, General dentist, DENISE E. VAN DIERMEN, Department of Oral and Maxillofacial Surgery, Academic Centre for Dentistry, Amsterdam, The Netherlands, IRENE H. A. AARTMAN, Department of Social Dentistry and Behavioral Sciences, Academic Centre for Dentistry, Amsterdam, The Netherlands, HUGO S. A. HEYMANS Emma Children’s Hospital, Academic Medical Centre, Amsterdam, The Netherlands
    The team was led by Claar D. Wierink, and looked at a group of 81 children, 53 who were known to have celiac disease, and 28 of whom served as a control group.
    The children underwent examinations from 2003-2004 and the Oral Surgery Outpatient Clinic of the Academic Medical Center in Amsterdam. 29 (55%) of the 53 children with celiac disease showed enamel defects, compared with 5 (18%) of the 28 non-celiac control subjects.
    Enamel defects were diagnosed as being specific in 20 of the 53 children with celiac disease, compared with only 1 (4%) of the 28 control subjects. Overall, children with celiac disease showed more specific enamel defects than did the control subjects.
    From these results, the researchers concluded that dentists might have a significant role to play in the early screening of patients who have undiagnosed celiac disease.
    International Journal of Paediatric Dentistry 2007

    Destiny Stone
    Celiac.com 06/24/2010 - Scientists have previously seen a nuclear fluorescence reactivity (NFR) pattern on monkey esophagus in sections which were exposed to celiac disease patients that were sera positive for anti-endomysium antibodies (EMA). Because of this prior knowledge, scientists created a new study to illustrate the NFR, to study  NFR positive results in connection with gluten withdrawal, and also to assess  the possible role of NFR in celiac disease follow-up's.
    For twelve months, scientists closely evaluated twenty untreated celiac patients, eighty-seven treated celiac patients, and fifteen healthy control subjects. Scientists incubated the sera of all 122 patients on monkey esophagus sections. The goal was to evaluate the existence of NFR by indirect immunofluorescence analysis.
    To asses the rate of NFR in culture supernatants, duodenal mucosa samples from treated celiac patients were challenged with gliadin peptides. Scientists evaluated the reactivity of NFR immunoglobulins (Igs) response to the nuclear extract of human intestinal cells. What they found was that serum NFR was visible in all untreated celiac patients and it persisted for up to 151 +/-37 days from gluten withdrawal. It reappeared in treated celiac patents when they did not stick to their dietary restrictions.
    Serum NFR was also present in two of the healthy control subjects. NFR presented itself before EMA,  in culture supernatants of celiac intestinal mucosa that was challenged with gliadin peptides. The Igs responsible for NFR were labeled as, “IgA2 Subclass”. The NFR had different results than the EMA and anti-nuclear antibodies, although they reacted with two nuclear antigens of 65 and 49 kDa. Thus, a new auto-antibody  named NFR, which is related to celiac disease, was depicted.
    In conclusion, the studies of NFR have demonstrated that NFR detection has potential to be used as a beneficial tool in monitoring compliance of a gluten-free diet, as it has the ability to  diagnose
    slight dietary shifts pertaining to gluten.
    Source:

    Clinical and Experimental Immunology


    Destiny Stone
    Celiac.com 07/02/2010 - Serological screening of healthy volunteers from around the world estimates that the prevalence for celiac disease is approximately 0.5%- 1% of the total population. However, a recent meta-analysis denotes that the actual ratio of known or undiagnosed celiac cases is closer to 1 in 7 people. Due to knowledge of celiac, acute clinical suspicion, and increased endoscopy accessibility some areas have reported celiac prevalence as high as 5.2%; suggesting that there is a considerable gap in effectively detecting new cases of celiac disease.
    Researchers further investigated the statistics on celiac disease prevalence by evaluating the incidence of celiac disease among “adult out-patients biopsied during upper endoscopy with typical and atypical symptoms”. One hundred and fifty out-patients including 94 women and 56 men with a median age of 45, were enrolled for the study between January 2007 and December 2008.
    There is no current standard classification for endoscopic lesions found from celiac disease. As such, this study used a method of classification where-as patients were labeled as; normal, mild, moderate, or severe. To detect villous atrophy, biopsy's were  taken from patients that were only presenting endoscopic appearances, which are indicative of celiac disease. Results which had t-TGA levels greater than 24 U/mL were considered positive for celiac disease. Patients were also positively diagnosed as celiac if they exhibited some degree of histological abnormality.
    Of the hundred and fifty subjects studied, twelve were diagnosed positively for celiac disease, and nine of them were women. The most commonly exhibited gastrointestinal pathology diagnosed in the study,  was gatroduodenitis peptic ulcer.  All of the subjects that had biopsy proven t-TGA, had positive antibodies, and the values of t-TGA increased depending on the intensity of the mucosal lesions. Additionally, all subjects were assessed for the existence of gastrointestinal and extra-intestinal symptoms.
    Typical gastrointestinal symptoms of celiac include diarrhea, anemia and weight loss, as evident in 58.32% of the subjects studied, while  atypical symptoms were present in 25% of the test subjects.
    41.66% of the subjects had iron deficiency anemia(IDA), 8.33% had osteopenia, 16.66% had hypocalcaemiaia and hypomagnesaemia. Additionally, extra-intestinal symptoms associated with gastrointestinal manifestations were found in 16.66% of the subjects that had astenia, and in 41.55% of the subjects with weight loss.
    Almost every celiac case observed demonstrated symptoms that progressively increased in severity.  No differences were observed among patients in the control group, and in the celiac patients with  regard to gastrointestinal problems and discomforts. However, IDA was observed most frequently in patients with celiac disease than in the control group.
    All patients that were diagnosed were recommended to strictly adhere to a gluten-free diet. One person refused to comply with the diet, but the other 90% followed the diet for one year. Of the patients following a gluten-free diet, a total histological response was observed. Severity of mucosal lesions decreased in 70% of the subjects, and all subjects were asymptomatic after one year on a gluten-free diet. The final incidence of celiac disease in the study was 6%.
    Screening studies such as these, demonstrate that the prevalence of celiac disease is increasing. When duodenal biopsy was preformed in patients during routine upper gastrointestinal endoscopy, the  incidence of celiac disease was observed at rates as high as 12%. Additionally, when clinical presentations of symptoms like diarrhea, anemia, and weight loss are used as screening criteria for celiac, increased rates of celiac disease diagnosis' were evident.
    Strict adherence to a completely gluten-free diet is still the only cure for celiac disease. Increased doctor and patient awareness of celiac, as well as an increase in celiac screening (especially for patients with typical celiac symptoms or atypical symptoms untreated by standard methods)  is still needed to avoid more cases of undiagnosed celiac disease, and to eliminate unnecessary suffering for those misdiagnosed or undiagnosed.
    Source:

    Journal of Experimental Medical & Surgical Research, Year XVII · Nr.1/2010 · Pag.23 -27

    Jefferson Adams
    Celiac.com 06/15/2012 - Diagnosing celiac disease can be challenging for doctors if a patient has already started a gluten-free diet, and/or when test results are inconsistent.
    A research team set out to evaluate the in vitro gliadin challenge in such patients. Researchers included Raffaella Tortora MD; Ilaria Russo PhD; Giovanni D De Palma MD; Alessandro Luciani PhD; Antonio Rispo MD; Fabiana Zingone MD; Paola Iovino MD; Pietro Capone MD; and Carolina Ciacci MD
    They are variously affiliated with the Department of Clinical and Experimental Medicine at Federico II University of Naples in Naples, Italy; the Department of Surgery, Endoscopy Unit at Federico II University of Naples in Naples, Italy; the Institute of Pediatrics at the University of Foggia in Foggia, Italy; and the University of Salerno, School of Medicine, Gastroenterology at Campus di Baronissi in Salerno, Italy.
    For their study, the team included 57 patients without celiac disease (negative controls), 166 patients with untreated celiac disease and 55 patients with celiac disease following a gluten-free diet (positive controls), and 59 patients with difficult diagnosis.
    The team conducted duodenal biopsies on all patients which provided the data for diagnosing the celiac disease and for the in vitro evaluation of the gliadin-induced mucosal expression of seven inflammatory markers: PY99, ICAM-1 (intercellular cell adhesion molecule), HLA-DR, CD3, CD25, CD69, and transglutaminase 2 IgA.
    As part of their diagnostic work-up for celiac disease, the team included a test for specific serum antibodies. The team asked patients in the difficult diagnosis group to discontinue their gluten-free diets to that they could test for antibodies under untreated conditions.
    To maintain statistical accuracy, the team used the area under the receptor-operated curve (ROC) to analyze the results.
    They found that HLA-DR was most accurate in diagnosing celiac disease on negative controls and positive controls, excluding patients on a gluten-free diet (area under ROC=0.99). Test accuracy did not increase by combining HLA-DR data with data of other markers.
    The results were similar in the 39 patients of the difficult diagnosis group who underwent the test for celiac disease-specific antibodies under untreated conditions.
    Finally, the results showed that in vitro response of mucosal HLA-DR to gliadin is an accurate tool for diagnosing celiac disease, including in patients with difficult diagnosis.
    Source:
    The American Journal of Gastroenterology. 2012;107(1):111-117.

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