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    Seven Years and Counting: FDA Drops Ball on Gluten-free Standards


    Jefferson Adams

    Celiac.com 08/10/2011 - For growing numbers of Americans, and millions overall, it is important to eat food that is gluten-free. For these people, maintaining good health, and avoiding serious and unpleasant side effects means avoiding gluten, a protein found in wheat, rye and barley.


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    However, the question of what, exactly is meant by a food label that claims the food to be "gluten-free" has continued to elude the FDA for the last seven years.

    Because the FDA has no current standard for the term, "gluten-free" means essentially whatever any given manufacturer wants it to mean. Thus, a "gluten-free" label does not mean that a food is free of any and all gluten, or even that it's free of all but trace amounts.

    There should be a gluten-free standard by now, but there is not. In 2004, Congress passed a law requiring the Food and Drug Administration to define the phrase 'gluten-free' by 2008. That deadline passed with the FDA providing no such definition, and we still have no official ruling today, in 2011.

    For people who must avoid gluten, doing so is essential to maintaining good health. However, avoiding gluten in processed products, even those that are gluten-free in theory, can be a challenge. Also, to be fair, there can be unforeseen challenges to establishing these standards. Sometimes products that seem to contain gluten-free ingredients - corn tortillas, say, or roasted peanuts - can pick up traces of gluten during processing.

    Often, gluten can hide deep inside an ingredient list, as such ingredients as "caramel coloring," "emulsifiers," "natural juices" and dozens of other common additives may or may not contain gluten, depending on where and how those ingredients were made.

    A "gluten-free" label ought to offer peace of mind, but so far, the phrase has been better for corporate bottom lines than for consumers. While the FDA has dithered about the meaning of "gluten-free," the market for those products has exploded. In 2003, it was $100 million; next year, it's estimated to be $2.6 billion.

    Some manufacturers go to great lengths to ensure that their gluten-free products are, in fact, free of gluten. Many test ingredients and scrupulously avoid contamination in their factories. Many also test final products to make sure they are safely gluten-free. Other manufacturers do none of that. And without a uniform standard for labels, people at risk can't reliably know the difference.

    The Center for Celiac Research has faulted the FDA for spending far too much time on studies. The group calls for the agency to act quickly to establish a uniform definition. Celiac.com concurs one-hundred percent.

    Millions of Americans with celiac disease and gluten intolerance deserve to be able to shop for and eat foods that are reliably gluten-free.

    This article echoes an editorial in the Houston Chronicle, titled: Sickening - After seven years, why can't the FDA define 'gluten-free'?

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    Guest CeliBelli

    Posted

    Chastising the FDA for dithering over endless studies is a good start, but you don't point out that they've just opened another comment period. This is the time to motivate all in the Celiac community to take advantage of this opportunity to give the FDA a piece of our mind and tell them to get on with it.

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    Chastising the FDA for dithering over endless studies is a good start, but you don't point out that they've just opened another comment period. This is the time to motivate all in the Celiac community to take advantage of this opportunity to give the FDA a piece of our mind and tell them to get on with it.

    Please see the "Related Links" above, as we did previously publish an article on the re-opening of the comment period.

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    Continuing to obfuscate the term "gluten free" is right in line with the Fraud and Death Administration: Big Pharma is probably paying them to drag their feet because there is so much money to be made off of people suffering from gluten in their diets.

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    Guest Jefferson Adams

    Posted

    Please see the related article on the new FDA comment period for 'gluten-free.'

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  • Related Articles

    Scott Adams
    This update comes to us from Frederik Willem Janssen, The Netherlands: fwjanssen@WXS.NL
    About a week ago I promised to post info about agenda item 4 (Gluten Free Food) as dealt with at the meeting of Codex Alimentarius NFSDU (Nutrition and Food for Special Dietary Uses) which was held in September in Berlin Germany. As usual this meeting starts on Monday and continues till Wednesday, Thursday is a day off (time for the secretariat to draw resolutions) and on Friday these draft resolutions are discussed. Unfortunately I wasnt able to stay till Friday. However, the resolutions as discussed on Friday were handed to me afterwards however and I pass them with some corrective changes accepted during that day. For those of you who have no interest in reading this clerical stuff I summarize:
    The proposed limits (20) for food gluten-free by nature and 200 for food "rendered gluten-free" will stay between square brackets (so no decision has been made). The same holds for oats, awaiting further toxicological data about its celiac-toxicity it should be considered as toxic. The main obstacle for finalizing the standard is the lack of an appropriate method of analysis. Progress has been made but still not to that extent that enforcing agencies can be satisfied. Maybe we will see some progress in the next 2 years!
    Proposed Revisions: Alinorm 99/26, Draft Revised Standards for Gluten-Free Foods (Agenda Item 4):
    31. The Committee recalled that the Twenty-second Session of the CAC adopted the Proposed Draft Standard for Gluten-Free Foods at Step 5 while recommending that comments on methods of analysis and on amounts of gluten in gluten free foods should be taken into account when finalizing the standard. The Committee noted that without an appropriate method of analysis it was not scientifically justified to advance the Draft further.
    32. The Delegation of Sweden introduced their recent study on gluten determination in foods by an enzyme immunoassay using a monoclonal antibody against omega-gliadin (CRD 33), noting that the detection limit of the method (ref. AOAC 991.19) was about 20 - 40 ppm and the repeatability was acceptable. Some Delegations pointed out that the method presented raised some technical concerns: it was performed only on wheat and due to this, uncertainty exists as regards its applicability to other cereals. There were also concerns about the reproducibility of the method. It measured only omega-gliadin and other gliadins should also be taken into account. The need of further improvement was raised. Spain expressed concern about setting units where no method of analysis is available and not all the different types of gliadins can be detected.
    33. The Committee noted that in some cases a proprietary method was the most specific way to detect an analyte, such as in the case of gluten detection. Since Codex had not endorsed these techniques as methods of analysis of Codex, the CCMAS (Codex committee on Methods of Analysis and Sampling) should consider this problem.
    34. Several delegations suggested that the Committee should ask FAO and WHO to convene an Expert Consultation to address the issue of the level and the method of analysis. Other delegations proposed to consult the CCMAS on this issue. The Secretariat informed the Committee that on the request of the CCFL (Codex committee on Food Labeling), JECFA (Joint expert committee on Food Additives) was prepared to consider the question of hypersensitivity at its 53rd Session (June 1999) and the intolerance to gluten might be discussed in this context. The Secretariat recalled that the role of the CCMAS was to endorse methods of analysis proposed by specialized Committees and the CCNFSDU needed to specify the method.
    35. Several delegations and the Observer from the AAC (Association des Amidonneries Cooperative) proposed that the discussion of this draft should be adjourned until a reliable method of analysis became available. Other delegations were in favor of continuing work on it in order to meet the urgent need of the patients suffering from coeliac disease and proposed to advance the proposed draft for a single level of 200 ppm to step 8. Taking into account the absence of an appropriate and accurate method of analysis, it was proposed to maintain the gluten free level at 200 ppm for all foods and to include a new preamble suggesting the a revision of the standard when a method of analysis or new scientific evidence became available.
    36. While concerning the proposed definition of "gluten-free" foods, several delegations wanted to point out that the current approach was confusing and misleading the consumer and that the level should be uniform for all foods. However, other delegations and the Observer from AOECS stressed the need for two levels with regard to the naturally gluten free foods and the products which had been rendered gluten free. The Committee noted that the proposed term "gluten-free" might mislead the consumer and recognized that the term "low or reduced in gluten" should be considered.
    37. The Observer from AOECS, supported by some delegations, expressed the view that the level of 200 ppm for all gluten-free foods was too high to protect coeliacs and the gluten level should refer only to the end product for better consumer protection.
    38. The Delegation of Finland proposed to remove the oats from the list as scientific studies showed that oats can be tolerated by celiacs and allows to provide dietary fibers for coeliacs. The Observer from AOECS, supported by some delegations, stressed that the square brackets on oats should be removed as oats might have negative impact on the health of coeliacs and that the medical experts had not reached consensus on this issue.
    39. The Committee recognized that the development of reliable method of analysis of gluten was the key point of this discussion and that the development of the method should be encouraged by all means. Status of the Draft Revised Standard for Gluten-Free Foods
    40. The Committee agreed to leave the text of the draft as it was in CX/NFSDU 98/4 and to return it to Step 6 for further consideration. The Committee also agreed that the question regarding the proprietary techniques should be raised to the CCMAS as a general matter.
    The following documents were discussed during the meeting: CX/NFSDU 98/4 - Add 1 (Comments from Australia, Spain, UK, AAC, ISDI); CX/NFSDU 98/4 - Add 2 (AOECS); CRD 3 (Uruguay, ISDI); CRD 13 (USA); CRD 21 (Spain); CRD 33 = CRD 42 (Sweden); CRD 44 (India); CRD 51 (Norway).

    Scott Adams
    Celiac.com 11/25/2003 - On Friday, November 21, 2003, the Senate HELP Committee took a major step toward improving the nations food labeling laws. The Committee, led by Senator Judd Gregg (R-NH) and Senator Edward Kennedy (D-MA), unanimously passed legislation requiring the top 8 allergens -- peanuts, tree nuts, eggs, milk, soybeans, shellfish, fish, and wheat -- to be listed on food labels by their common or usual name, or by source of the ingredient.
    The measure also requires the Secretary of HHS to develop rules for the use of the term gluten-free on food labels.
    The "Food Allergen Labeling and Consumer Protection Act of 2003" is now Title II of S. 741.
    Todays action by the HELP Committee demonstrates that our unified efforts are making a difference. The SINGLE voice of the celiac community was heard, and taken seriously.
    All of us deserve credit for getting this far. Next up, the Senate Floor.
    Thanks for your help,
    Andrea Levario and Allison Herwitt
    Co-Chairs, Legislative Project
    American Celiac Task Force
    http://www.celiaccenter.org/taskforce.asp
    E-mail: actf@fogworks.net

    Scott Adams
    Celiac.com 05/25/2004 - On April 27, 2004, for the first time, individuals with Celiac Disease testified before a Congressional Committee.
    Lisa Murphy, and her son, Colin, represented the ACTF before the House Appropriations Subcommittee on Labor, HHS, and Education. They did an outstanding job outlining what celiac disease is, who it affects, the need for NIDDK to develop a research plan for celiac disease, as well as the need for greater physician and patient education (The Murphy family, of Chappaqua, NY, was featured in a Feb. 2004 Parents magazine article about celiac disease).
    The Labor-HHS Subcommittee determines how much money NIH receives each year. Having individuals with Celiac Disease provide information about the disease is critical to securing funding for research.
    After hearing the testimony, Subcommittee Chairman, Ralph Regula (R-OH), asked if food labels were a problem for celiacs. Not missing a beat, Lisa offered an emphatic, Yes, then highlighted problems she has encountered. Rep. Nita Lowey (D-NY), sponsor of H.R. 3684, the Food Allergen Labeling and Consumer Protection Act, and member of the Subcommittee, explained the bill was drafted to help individuals like Lisa, and Colin.
    The celiac community has waited a very long time for this incredible opportunity.
    The American Celiac Task Force is grateful to the entire Murphy family for graciously agreeing toshare their story, and for helping to make this historic day possible.
    Allison Herwitt
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    Jefferson Adams
    Celiac.com 03/18/2015 - A man who suffers from celiac disease has sued the FDA for allowing gluten to be used as a coating on prescription drug and over-the-counter medicine capsules.
    Remember, people with celiac disease can suffer intestinal damage when they consume gluten. This can damage can lead to neurological, among other disorders.
    The man, Michael Weber, was taking a generic drug seven years ago, and developed side effects consistent with ingesting gluten.
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    Weber went on to petition the FDA to either eliminate wheat gluten in medicines or require new labeling on drugs containing the protein.
    In 2011, the FDA sought public comments about the issue. In 2014, the FDA issued gluten-free definitions and labeling standards for commercial foods, but has failed to act on drugs. So Weber has now filed a lawsuit to demand the FDA do something. The complaint can be read here.
    This raises a couple of questions: Do people with celiac disease deserve to know if there is gluten in their medicine? Do they deserve access to medicines that are gluten-free? Should the FDA definitions and labeling standards also apply to drugs and medicines?

  • Recent Articles

    Jefferson Adams
    Celiac.com 06/16/2018 - Summer is the time for chips and salsa. This fresh salsa recipe relies on cabbage, yes, cabbage, as a secret ingredient. The cabbage brings a delicious flavor and helps the salsa hold together nicely for scooping with your favorite chips. The result is a fresh, tasty salsa that goes great with guacamole.
    Ingredients:
    3 cups ripe fresh tomatoes, diced 1 cup shredded green cabbage ½ cup diced yellow onion ¼ cup chopped fresh cilantro 1 jalapeno, seeded 1 Serrano pepper, seeded 2 tablespoons lemon juice 2 tablespoons red wine vinegar 2 garlic cloves, minced salt to taste black pepper, to taste Directions:
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    Cover and refrigerate for at least 1 hour. 
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    Serve is a bowl with tortilla chips and guacamole.

    Dr. Ron Hoggan, Ed.D.
    Celiac.com 06/15/2018 - There seems to be widespread agreement in the published medical research reports that stuttering is driven by abnormalities in the brain. Sometimes these are the result of brain injuries resulting from a stroke. Other types of brain injuries can also result in stuttering. Patients with Parkinson’s disease who were treated with stimulation of the subthalamic nucleus, an area of the brain that regulates some motor functions, experienced a return or worsening of stuttering that improved when the stimulation was turned off (1). Similarly, stroke has also been reported in association with acquired stuttering (2). While there are some reports of psychological mechanisms underlying stuttering, a majority of reports seem to favor altered brain morphology and/or function as the root of stuttering (3). Reports of structural differences between the brain hemispheres that are absent in those who do not stutter are also common (4). About 5% of children stutter, beginning sometime around age 3, during the phase of speech acquisition. However, about 75% of these cases resolve without intervention, before reaching their teens (5). Some cases of aphasia, a loss of speech production or understanding, have been reported in association with damage or changes to one or more of the language centers of the brain (6). Stuttering may sometimes arise from changes or damage to these same language centers (7). Thus, many stutterers have abnormalities in the same regions of the brain similar to those seen in aphasia.
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    Whatever the reason that stuttering has not been reported in the medical literature in association with gluten ingestion, a number of personal disclosures and comments suggesting a connection between gluten and stuttering can be found on the Internet. Abid Hussain, in an article about food allergy and stuttering said: “The most common food allergy prevalent in stutterers is that of gluten which has been found to aggravate the stutter” (10). Similarly, Craig Forsythe posted an article that includes five cases of self-reporting individuals who believe that their stuttering is or was connected to gluten, one of whom also experiences stuttering from foods containing yeast (11). The same site contains one report of a stutterer who has had no relief despite following a gluten free diet for 20 years (11). Another stutterer, Jay88, reports the complete disappearance of her/his stammer on a gluten free diet (12). Doubtless there are many more such anecdotes to be found on the Internet* but we have to question them, exercising more skepticism than we might when reading similar claims in a peer reviewed scientific or medical journal.
    There are many reports in such journals connecting brain and neurological ailments with gluten, so it is not much of a stretch, on that basis alone, to suspect that stuttering may be a symptom of the gluten syndrome. Rodney Ford has even characterized celiac disease as an ailment that may begin through gluten-induced neurological damage (13) and Marios Hadjivassiliou and his group of neurologists and neurological investigators have devoted considerable time and effort to research that reveals gluten as an important factor in a majority of neurological diseases of unknown origin (14) which, as I have pointed out previously, includes most neurological ailments.
    My own experience with stuttering is limited. I stuttered as a child when I became nervous, upset, or self-conscious. Although I have been gluten free for many years, I haven’t noticed any impact on my inclination to stutter when upset. I don’t know if they are related, but I have also had challenges with speaking when distressed and I have noticed a substantial improvement in this area since removing gluten from my diet. Nonetheless, I have long wondered if there is a connection between gluten consumption and stuttering. Having done the research for this article, I would now encourage stutterers to try a gluten free diet for six months to see if it will reduce or eliminate their stutter. Meanwhile, I hope that some investigator out there will research this matter, publish her findings, and start the ball rolling toward getting some definitive answers to this question.
    Sources:
    1. Toft M, Dietrichs E. Aggravated stuttering following subthalamic deep brain stimulation in Parkinson’s disease--two cases. BMC Neurol. 2011 Apr 8;11:44.
    2. Tani T, Sakai Y. Stuttering after right cerebellar infarction: a case study. J Fluency Disord. 2010 Jun;35(2):141-5. Epub 2010 Mar 15.
    3. Lundgren K, Helm-Estabrooks N, Klein R. Stuttering Following Acquired Brain Damage: A Review of the Literature. J Neurolinguistics. 2010 Sep 1;23(5):447-454.
    4. Jäncke L, Hänggi J, Steinmetz H. Morphological brain differences between adult stutterers and non-stutterers. BMC Neurol. 2004 Dec 10;4(1):23.
    5. Kell CA, Neumann K, von Kriegstein K, Posenenske C, von Gudenberg AW, Euler H, Giraud AL. How the brain repairs stuttering. Brain. 2009 Oct;132(Pt 10):2747-60. Epub 2009 Aug 26.
    6. Galantucci S, Tartaglia MC, Wilson SM, Henry ML, Filippi M, Agosta F, Dronkers NF, Henry RG, Ogar JM, Miller BL, Gorno-Tempini ML. White matter damage in primary progressive aphasias: a diffusion tensor tractography study. Brain. 2011 Jun 11.
    7. Lundgren K, Helm-Estabrooks N, Klein R. Stuttering Following Acquired Brain Damage: A Review of the Literature. J Neurolinguistics. 2010 Sep 1;23(5):447-454.
    8. [No authors listed] Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises. Case 43-1988. A 52-year-old man with persistent watery diarrhea and aphasia. N Engl J Med. 1988 Oct 27;319(17):1139-48
    9. Molteni N, Bardella MT, Baldassarri AR, Bianchi PA. Celiac disease associated with epilepsy and intracranial calcifications: report of two patients. Am J Gastroenterol. 1988 Sep;83(9):992-4.
    10. http://ezinearticles.com/?Food-Allergy-and-Stuttering-Link&id=1235725 
    11. http://www.craig.copperleife.com/health/stuttering_allergies.htm 
    12. https://www.celiac.com/forums/topic/73362-any-help-is-appreciated/
    13. Ford RP. The gluten syndrome: a neurological disease. Med Hypotheses. 2009 Sep;73(3):438-40. Epub 2009 Apr 29.
    14. Hadjivassiliou M, Gibson A, Davies-Jones GA, Lobo AJ, Stephenson TJ, Milford-Ward A. Does cryptic gluten sensitivity play a part in neurological illness? Lancet. 1996 Feb 10;347(8998):369-71.

    Jefferson Adams
    Celiac.com 06/14/2018 - Refractory celiac disease type II (RCDII) is a rare complication of celiac disease that has high death rates. To diagnose RCDII, doctors identify a clonal population of phenotypically aberrant intraepithelial lymphocytes (IELs). 
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    To that end, a research team recently set out to try to get some information about the frequency and importance of clonal T cell receptor (TCR) gene rearrangements (TCR-GRs) in small bowel (SB) biopsies of patients without RCDII. The research team included Shafinaz Hussein, Tatyana Gindin, Stephen M Lagana, Carolina Arguelles-Grande, Suneeta Krishnareddy, Bachir Alobeid, Suzanne K Lewis, Mahesh M Mansukhani, Peter H R Green, and Govind Bhagat.
    They are variously affiliated with the Department of Pathology and Cell Biology, and the Department of Medicine at the Celiac Disease Center, New York Presbyterian Hospital/Columbia University Medical Center, New York, USA. Their team analyzed results of TCR-GR analyses performed on SB biopsies at our institution over a 3-year period, which were obtained from eight active celiac disease, 172 celiac disease on gluten-free diet, 33 RCDI, and three RCDII patients and 14 patients without celiac disease. 
    Clonal TCR-GRs are not infrequent in cases lacking features of RCDII, while PCPs are frequent in all disease phases. TCR-GR results should be assessed in conjunction with immunophenotypic, histological and clinical findings for appropriate diagnosis and classification of RCD.
    The team divided the TCR-GR patterns into clonal, polyclonal and prominent clonal peaks (PCPs), and correlated these patterns with clinical and pathological features. In all, they detected clonal TCR-GR products in biopsies from 67% of patients with RCDII, 17% of patients with RCDI and 6% of patients with gluten-free diet. They found PCPs in all disease phases, but saw no significant difference in the TCR-GR patterns between the non-RCDII disease categories (p=0.39). 
    They also noted a higher frequency of surface CD3(−) IELs in cases with clonal TCR-GR, but the PCP pattern showed no associations with any clinical or pathological feature. 
    Repeat biopsy showed that the clonal or PCP pattern persisted for up to 2 years with no evidence of RCDII. The study indicates that better understanding of clonal T cell receptor gene rearrangements may help researchers improve refractory celiac diagnosis. 
    Source:
    Journal of Clinical Pathologyhttp://dx.doi.org/10.1136/jclinpath-2018-205023

    Jefferson Adams
    Celiac.com 06/13/2018 - There have been numerous reports that olmesartan, aka Benicar, seems to trigger sprue‐like enteropathy in many patients, but so far, studies have produced mixed results, and there really hasn’t been a rigorous study of the issue. A team of researchers recently set out to assess whether olmesartan is associated with a higher rate of enteropathy compared with other angiotensin II receptor blockers (ARBs).
    The research team included Y.‐H. Dong; Y. Jin; TN Tsacogianis; M He; PH Hsieh; and JJ Gagne. They are variously affiliated with the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School in Boston, MA, USA; the Faculty of Pharmacy, School of Pharmaceutical Science at National Yang‐Ming University in Taipei, Taiwan; and the Department of Hepato‐Gastroenterology, Chi Mei Medical Center in Tainan, Taiwan.
    To get solid data on the issue, the team conducted a cohort study among ARB initiators in 5 US claims databases covering numerous health insurers. They used Cox regression models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for enteropathy‐related outcomes, including celiac disease, malabsorption, concomitant diagnoses of diarrhea and weight loss, and non‐infectious enteropathy. In all, they found nearly two million eligible patients. 
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    After PS matching comparing olmesartan to other ARBs, hazard ratios were 1.21 (95% CI, 1.05‐1.40), 1.00 (95% CI, 0.88‐1.13), 1.22 (95% CI, 1.10‐1.36) and 1.04 (95% CI, 1.01‐1.07) for each outcome. Patients aged 65 years and older showed greater hazard ratios for celiac disease, as did patients receiving treatment for more than 1 year, and patients receiving higher cumulative olmesartan doses.
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    Source:
    Alimentary Pharmacology & Therapeutics

    Jefferson Adams
    Celiac.com 06/12/2018 - A life-long gluten-free diet is the only proven treatment for celiac disease. However, current methods for assessing gluten-free diet compliance are lack the sensitivity to detect occasional dietary transgressions that may cause gut mucosal damage. So, basically, there’s currently no good way to tell if celiac patients are suffering gut damage from low-level gluten contamination.
    A team of researchers recently set out to develop a method to determine gluten intake and monitor gluten-free dietary compliance in patients with celiac disease, and to determine its correlation with mucosal damage. The research team included ML Moreno, Á Cebolla, A Muñoz-Suano, C Carrillo-Carrion, I Comino, Á Pizarro, F León, A Rodríguez-Herrera, and C Sousa. They are variously affiliated with Facultad de Farmacia, Departamento de Microbiología y Parasitología, Universidad de Sevilla, Sevilla, Spain; Biomedal S.L., Sevilla, Spain; Unidad Clínica de Aparato Digestivo, Hospital Universitario Virgen del Rocío, Sevilla, Spain; Celimmune, Bethesda, Maryland, USA; and the Unidad de Gastroenterología y Nutrición, Instituto Hispalense de Pediatría, Sevilla, Spain.
    For their study, the team collected urine samples from 76 healthy subjects and 58 patients with celiac disease subjected to different gluten dietary conditions. To quantify gluten immunogenic peptides in solid-phase extracted urines, the team used a lateral flow test (LFT) with the highly sensitive and specific G12 monoclonal antibody for the most dominant GIPs and an LFT reader. 
    They detected GIPs in concentrated urines from healthy individuals previously subjected to gluten-free diet as early as 4-6 h after single gluten intake, and for 1-2 days afterward. The urine test showed gluten ingestion in about 50% of patients. Biopsy analysis showed that nearly 9 out of 10 celiac patients with no villous atrophy had no detectable GIP in urine, while all patients with quantifiable GIP in urine showed signs of gut damage.
    The ability to use GIP in urine to reveal gluten consumption will likely help lead to new and non-invasive methods for monitoring gluten-free diet compliance. The test is sensitive, specific and simple enough for clinical monitoring of celiac patients, as well as for basic and clinical research applications including drug development.
    Source:
    Gut. 2017 Feb;66(2):250-257.  doi: 10.1136/gutjnl-2015-310148.