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    General Mills Describes the Success of its Gluten Detection System


    Jefferson Adams


    • General Mills uses a proprietary optical sorting process to make oats meet gluten-free standards.


    Image Caption: Photo: CC--Bernard Sprague. NZ

    Celiac.com 11/03/2017 - Talk about finding needles in a haystack. Imagine, if you will, sifting through rail cars full of oats and plucking out nearly every stray grain of wheat, barley or rye so that the final product tests at under 20 ppm, instead of the original 200 ppm to 1,000 ppm.


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    Quite a challenge, yes? It's a challenge General Mills take on every day as it produces Gluten Free Cheerios from raw oats into the final product. According to their website, General Mills ships 500,000 cases of Cheerios each week.

    To do this, General Mills uses a proprietary optical sorting process, for which it has filed a patent with the US Patent Office. That process sifts through those rail cars of oats, with stray gluten ranging from 200 ppm to 1,000 ppm, and "takes it down to less than 20" ppm, said Paul Wehling, principal scientist for General Mills.

    Mr. Wehling told audience members at the annual meeting of AACC International at Cereals 17 in San Diego on Oct. 9, that the General Mills sorting process achieves a "2- to 3-log reduction of the gluten."

    To verify their oat sorting results, General Mills uses enzyme-linked immunosorbent assay (ELISA) testing and visual inspection to spot and eliminate gluten-containing grains such as wheat.

    The company uses hand inspection in place of lateral flow testing, as they find that "hand inspection is much more efficient because we can look at quite a few more seeds," Mr. Wehling said.

    That process would seem to be validated by Laura K. Allred, regulatory and standards manager for the Gluten Intolerance Group, Auburn, Wash., which recommends companies use a combination of visual testing and ELISA testing.

    However, the General Mills process is not without critics. One of the more prominent voices in opposition to General Mills has been the Canadian Celiac Association (CCA).

    The CCA has made numerous statements questioning the process General Mills uses to create their Gluten-Free Cheerios, and other oat products.

    CCA statements, or statements attributed to the CCA include comments in an article published in October 26, 2017, in which Globalnews.ca writes "[CCA] expressed doubt in the company's mechanical sorting system and claim of 100 per cent removal of cross-contaminants."

    Candiangrocer.com reported in August 2016 that the CCA was, to paraphrase, "awaiting evidence showing the new line [of Gluten Free Cheerios] is 100% free of gluten." It is unclear what the CCA means by such terms as "100% gluten-free," "100 percent removal," and "100 percent safe for people with celiac disease."

    Is the CCA hinting that the standard for gluten-free products should be 0 ppm?

    Besides voicing fear and concerns, and citing alleged complaints by members, the CCA never actually provided any evidence that Cheerios failed to meet the US and Canadian standard of 20 ppm allowable gluten, and were, thus, not gluten-free.

    The CBC reported on August 31 2016, that the "Canadian Celiac Association is warning against gluten-free Cheerios products over concerns the cereal is not 100 per cent safe for people with celiac disease."

    Again, the CCA made this recommendation based not on independent product testing, or on any confirmed accounts of gluten-exposure in people with celiac disease who had consumed Cheerios, but on "fear" and "concerns" driven by anecdotal evidence. Moreover, they seemingly disregarded overwhelming anecdotal evidence provided by people with celiac disease who say they eat Cheerios safely. The CCA has yet to provide a satisfactory response for their warnings, or to provide any clarification of their position regarding the safety of products that test under 20 ppm gluten for people with celiac disease.

    The FDA recently announced that 99.5% of products tested came in under the 20 ppm standard set by the FDA for labeling a product "gluten-free." In fact, only one of 750 samples taken from 250 products tested above 20 ppm. That product was recalled and the manufacturer corrected the problem. There has been no indication the Cheerios tested outside the FDA's gluten-free standard.

    That means that even an ambitious sorting process like the one developed by General Mills seems to be working as designed. It means that consumers can trust the FDA, and American gluten-free labels, and that consumers of gluten-free foods can buy with confidence.


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    I don't trust these brands at all. The only way something is truly gluten free is when there are zero wheat products mixed in or exposed to the product. Less than 20 ppm is still too much gluten for sensitive celiacs. There's too much room for error and some brands, like Bob's Red Mill, will just go on labeling their products gluten free when they have been contaminated with high levels of gluten. I have learned the hard way and spend my money on trusted brands like Enjoy Life which never mix their products with gluten.

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    Guest Celiac.com

    Posted

    I don't trust these brands at all. The only way something is truly gluten free is when there are zero wheat products mixed in or exposed to the product. Less than 20 ppm is still too much gluten for sensitive celiacs. There's too much room for error and some brands, like Bob's Red Mill, will just go on labeling their products gluten free when they have been contaminated with high levels of gluten. I have learned the hard way and spend my money on trusted brands like Enjoy Life which never mix their products with gluten.

    "Less than 20 ppm is still too much gluten for sensitive celiacs." Please explain, as this level is considered safe by experts and governments, and any company can have issues with cross contamination (even the company you mentioned does not grow its grains, ship them, mill them, etc.).

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    Guest Adonnya

    Posted

    I don't trust them. gluten-free Bisquik made me very ill. There can be cross contamination from the fields, in the air, and on the equipment. This is the second article concerning General Mills. What's the deal? Are they trying to convince us they are safe for their bottom line?

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    I agree with the Canadian Celiac Association's stand point. The term "Gluten-free" implies 0 ppm. I feel that something labeled gluten-free should be 0. If something is gluten LESS then maybe I'll take a chance, but it's me choosing not some large corporation...jf..

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    Guest Celiac.com

    Posted

    I agree with the Canadian Celiac Association's stand point. The term "Gluten-free" implies 0 ppm. I feel that something labeled gluten-free should be 0. If something is gluten LESS then maybe I'll take a chance, but it's me choosing not some large corporation...jf..

    Hopefully you understand that there is no testing that goes down to zero? If they made the labeling laws zero gluten, then no company would use the term on their packaging, and we would be right back where we were before there were labeling laws.

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    Guest sc'Que?

    Posted

    And yet... my local grocery has a section of freezers clearly labeled "GLUTEN-FREE" (along with a please read labels carefully CYA statement) that have 4 different non-gluten-free products planted right in the middle of a bank of 3 gluten-free-dedicated freezers. These are next to a longer section of "NATURAL LIVING" freezers with a wide range of both organic, diet-specific and gluten-reduced products. The non-gluten-free "blintzes" were reported to the store chain nearly 2 months ago, and followed up on 17 October 2017. And while there are now 2 freezer doors between the "Natural" and "gluten-free" freezers that are currently un-labeled, these blatantly non-gluten-free items still remain in the middle of the gluten-free freezers! When I brought this up tonight for the third time with the staff, the overnight freezer manager said he was aware of the complaints, and that the grocery chain had attempted to move the offending items to the other section of the freezers. But the company who sets the "floorplan" model for the section refused to let them do so! The outsourced management company is reputed to be called DPI. Research shows they are based in Canada. WHY IS A COMPANY IN CANADA TELLING A SMALL GROCERY CHAIN (BASED IN MD & PA) HOW THEY ARE TO ORGANIZE THEIR SHELVES??? THIS NONSENSE LEADS TO MANY PEOPLE GETTING SICK because no one seems to have any accountability within the immediate chain of command. IN ADDITION TO THIS PROBLEM of non-gluten-free product getting shelved beside gluten-free products GETTING FIXED... the paradigm of grocery chains outsourcing the floor plan management NEEDS TO STOP. There are local people who went to school for this sort of thing who can handle the floorplan (and within a general corporate framework) who can take responsibility for fixing these sorts of problems in short order... instead of it dragging on for months and months.

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    Guest Scott Adams

    Posted

    And yet... my local grocery has a section of freezers clearly labeled "GLUTEN-FREE" (along with a please read labels carefully CYA statement) that have 4 different non-gluten-free products planted right in the middle of a bank of 3 gluten-free-dedicated freezers. These are next to a longer section of "NATURAL LIVING" freezers with a wide range of both organic, diet-specific and gluten-reduced products. The non-gluten-free "blintzes" were reported to the store chain nearly 2 months ago, and followed up on 17 October 2017. And while there are now 2 freezer doors between the "Natural" and "gluten-free" freezers that are currently un-labeled, these blatantly non-gluten-free items still remain in the middle of the gluten-free freezers! When I brought this up tonight for the third time with the staff, the overnight freezer manager said he was aware of the complaints, and that the grocery chain had attempted to move the offending items to the other section of the freezers. But the company who sets the "floorplan" model for the section refused to let them do so! The outsourced management company is reputed to be called DPI. Research shows they are based in Canada. WHY IS A COMPANY IN CANADA TELLING A SMALL GROCERY CHAIN (BASED IN MD & PA) HOW THEY ARE TO ORGANIZE THEIR SHELVES??? THIS NONSENSE LEADS TO MANY PEOPLE GETTING SICK because no one seems to have any accountability within the immediate chain of command. IN ADDITION TO THIS PROBLEM of non-gluten-free product getting shelved beside gluten-free products GETTING FIXED... the paradigm of grocery chains outsourcing the floor plan management NEEDS TO STOP. There are local people who went to school for this sort of thing who can handle the floorplan (and within a general corporate framework) who can take responsibility for fixing these sorts of problems in short order... instead of it dragging on for months and months.

    What does this have to do with the article?

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    Guest Jefferson Adams

    Posted

    I don't trust them. gluten-free Bisquik made me very ill. There can be cross contamination from the fields, in the air, and on the equipment. This is the second article concerning General Mills. What's the deal? Are they trying to convince us they are safe for their bottom line?

    The issue is in the news lately. Also, the FDA just released their report on gluten-free product compliance. They tested hundreds of products, and found overwhelming compliance with gluten standards in food labeled gluten free. Overall, 99.5% of products tested were compliant. That means that American-made foods are likely not contaminated with gluten.

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    Guest Jefferson Adams

    Posted

    I don't trust these brands at all. The only way something is truly gluten free is when there are zero wheat products mixed in or exposed to the product. Less than 20 ppm is still too much gluten for sensitive celiacs. There's too much room for error and some brands, like Bob's Red Mill, will just go on labeling their products gluten free when they have been contaminated with high levels of gluten. I have learned the hard way and spend my money on trusted brands like Enjoy Life which never mix their products with gluten.

    I haven't seen any evidence to show that Bob's Red Mill products labeled "gluten-free"are contaminated with gluten. Where are you getting that? Also, the scientific evidence show that the vast majority of people with celiac tolerate gluten below 20 ppm, and that they experience gut healing and relief from symptoms. Remember, back in the days when there was no standard, there was simply no way to tell if anything was actually gluten-free or safe.

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    Guest Jefferson Adams

    Posted

    I agree with the Canadian Celiac Association's stand point. The term "Gluten-free" implies 0 ppm. I feel that something labeled gluten-free should be 0. If something is gluten LESS then maybe I'll take a chance, but it's me choosing not some large corporation...jf..

    Do you realize that if 0 ppm were used as a standard, then any trace of gluten could get a company sued. What company would claim to a product was "100% gluten-free?" How would you guarantee that standard? How would you test?

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    Jefferson Adams
    Celiac.com 04/24/2017 - The fallout continues from General Mills' recall of nearly 2 million boxes of Gluten Free Cheerios and Honey Nut Cheerios in 2015, which occurred after workers at a California plant accidentally loaded gluten-free oat flour into trucks that had been holding wheat flour, which contains gluten, and which then contaminated batches of "gluten-free" cereal produced with the grain from those trucks.
    In comments to the U.S. Ninth Circuit court, plaintiffs representing a proposed class of consumers claimed that a lower court had erred in dismissing their lawsuit on the grounds that the company's recall program made the claims baseless. They asked that the court allow their lawsuit against General Mills to continue. The suit is based on claims that the supposedly gluten-free Cheerios that had been made with the wrong flour, and that the cereal had sickened consumers.
    Lead plaintiff Christopher Hamilton told the panel that a refund program alone does not moot a claim for damages, as courts have held that, while refund programs do moot restitution claims, they do not moot claims for damages and injunctive relief, such as Hamilton's. "Indeed, in a case based on the exact facts present here, a court in California held that the Cheerios recall program did not moot a consumer's damages claim because the defendants did not satisfy the plaintiff's claims for statutory damages and injunctive relief," said Hamilton.
    Hamilton, who has celiac disease, brought his suit in March 2016 after buying the supposedly "gluten-free," wheat-contaminated Cheerios. One sample revealed 43 parts per million of gluten, more than twice the legal ceiling for the "gluten-free" label, Hamilton said in his complaint.
    Still, to the layperson, Hamilton's request for damages and injunctive relief invites questions. First, since the company issued a full product recall, what type of injunctive relief would they be seeking? Second, regarding damages, exactly what type of monetary damages would be claimed? Did these plaintiffs incur medical expenses, missed work or other costs? That is not made clear in these filings.
    When U.S. District Judge Michael McShane dismissed the original suit in July, he did so based on the fact that General Mills did issue a full product recall. In his statements on the matter, the judge wrote: "Rather than mitigate his damages by accepting General Mills' recall/refund offer, Hamilton is suing General Mills for false labeling, marketing and promotion of the product. Hamilton paints a discreet [sic] manufacturing mishap as a grand scheme of deceptive advertising, marketing and labeling." Judge McShane added, "I find this to be creative at best."
    But Hamilton says that he should be permitted to amend his complaint to include claims that the recall was delayed, and that the company was aware of complaints from sick consumers as early as July 2015. Hamilton also wishes to include allegations that General Mills deliberately ignored warnings from a dietitian that General Mills gluten-free testing was inferior.
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    Jefferson Adams
    Celiac.com 10/31/2017 - A press release by the Canadian Celiac Association announcing a label change for General Mills' Cheerios is drawing confusion and questions from numerous corners of the gluten-free community.
    The press release is also drawing pushback from General Mills, which called the CCA press release "inaccurate," and said it was "not based on facts."
    General Mills spokesman Mike Siemienas says that "the only thing the CCA got right is that General Mills is changing its label in Canada." Everything else, Siemienas, claimed, was based on opinion, not facts.
    Siemienas added that General Mills has made efforts to work with the CCA, but that the organization "had its opinions formed" in advance, and seemed unmoved by facts.
    Regarding Cheerios, a statement by General Mills reads: 

    "Each serving of Cheerios products in Canada are gluten free, as defined by the current regulatory standard of containing less than 20 ppm of gluten. General Mills Canada has made the decision to voluntarily remove the gluten-free label from our Cheerios products in Canada until Health Canada and The Canadian Food Inspection Agency (CFIA) publish a consistent testing protocol for products containing oats. At this time the product is not changing, just the label on the box. We look forward to labeling the Cheerios products in Canada as gluten free once consensus is reached on a consistent testing protocol for products containing oats."
    The full text of the original CCA press release appears below, but since this article was written: "The CCA retracts its statement of October 20, 2017 and replaces it with this statement due to errors in the original statement.":

    October 20, 2017 (Mississauga, ON) The Canadian Food Inspection Agency (CFIA) has made an announcement that the words "gluten-free" will be removed from all Cheerios package sold in Canada by January 1, 2018.
    The Canadian Celiac Association first objected to the claim in August 2016 and strongly recommended that people with celiac disease not consume the cereal, even though the box was labelled "gluten free".
    The announcement came in a letter addressed to a Canadian consumer who was one of many customer complaints to be filed against the products.
    "We are delighted to hear that the regulators have determined that the claim must be removed from the packages", said Melissa Secord, Executive Director of the Canadian Celiac Association. "Based on the advice of the members of our Professional Advisory Board, the experts of the Gluten-Free Certification Program, and other professionals working in the field, we believe that there is not adequate evidence to support the claim. When added to many reports from consumers with celiac disease reacting to eating the cereal, we believe this is the safe recommendation for Canadians."
    The CCA will follow up closely with the CFIA and Health Canada to continue to monitor this decision along with other products sold in Canada to ensure access to safe foods for people with celiac disease and gluten sensitivities.
    The CCA is currently working on a grant from Agriculture and Agrifood Canada to examine the scope of gluten contamination in oats grown in Canada, and to determine where the contamination occurs as the oats a processed (field, harvest, transport, processing). The project is scheduled to be completed in March 2018.
    Celiac disease is a medical condition in which the absorptive surface of the small intestine is damaged by a substance called gluten. This results in an inability of the body to absorb nutrients: protein, fat, carbohydrates, vitamins and minerals, which are necessary for good health.
    Gluten is a protein found in wheat, rye, triticale, barley. In the case of wheat, gliadin has been isolated as the toxic fraction. It is the gluten in the flour that helps bread and other baked goods bind and prevents crumbling. This feature has made gluten widely used in the production of many processed and packaged foods.
    The Canadian Celiac Association, the national voice for people who are adversely affected by gluten, is dedicated to improving diagnosis and quality of life.

    Jefferson Adams
    Celiac.com 10/27/2017 - Cereal maker General Mills has announced that it will no longer label their flagship cereal Cheerios as gluten-free in Canada.
    Has Canada Changed its Gluten-free Standards?
    No, the standard for labeling gluten-free foods in Canada remains same, at up to 20 ppm allowable gluten. Such foods are safe for the vast majority of people with celiac disease, according to both U.S. and Canadian regulatory agencies, the EU, celiac researchers and numerous celiac disease support groups. Health Canada, the agency responsible for setting food safety standards in Canada says that gluten levels below 20 ppm are safe for people with celiac disease. That is also the standard for gluten-free products in the United States and the EU.
    Have Cheerios Changed?
    No, the Gluten-Free Cheerios sold in the U.S. are the same Cheerios that are sold in Canada now, and the same Cheerios that will be sold in Canada after the labeling change. Cheerios routinely test below 20 ppm, and are currently labeled as gluten-free in both the U.S., and Canada. Cheerios has not been the subject of a mandated recall in with the U.S. or in Canada, which indicates that the product remains safe for the vast majority of people with celiac disease. So, Why is Cheerios Changing its Label in Canada?
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    As a result, cereal maker General Mills has announced that it will no longer label their flagship cereal Cheerios as gluten-free in Canada.
    General Mills stands by its testing process and said Cheerios sold in the U.S. will continue to carry the gluten-free label. A statement by General Mills reads: GM: 
    "Each serving of Cheerios products in Canada are gluten free, as defined by the current regulatory standard of containing less than 20 ppm of gluten. General Mills Canada has made the decision to voluntarily remove the gluten-free label from our Cheerios products in Canada until Health Canada and
    The Canadian Food Inspection Agency (CFIA) publish a consistent testing protocol for products containing oats. At this time the product is not changing, just the label on the box. We look forward to labeling the Cheerios products in Canada as gluten free once consensus is reached on a consistent testing protocol for products containing oats."
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    So, while Cheerios will no longer carry a gluten-free label in Canada, Canadian standards for gluten-free products have not changed, and remain the same as American standards, at up to 20 ppm allowable gluten. The Cheerios sold in Canada are no different than Cheerios sold in the United States, where they will still carry a gluten-free label.
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    So how, you may ask, is all this related to gluten? As a starting point, one report from the medical literature identifies a patient who developed aphasia after admission for severe diarrhea. By the time celiac disease was diagnosed, he had completely lost his faculty of speech. However, his speech and normal bowel function gradually returned after beginning a gluten free diet (8). This finding was so controversial at the time of publication (1988) that the authors chose to remain anonymous. Nonetheless, it is a valuable clue that suggests gluten as a factor in compromised speech production. At about the same time (late 1980’s) reports of connections between untreated celiac disease and seizures/epilepsy were emerging in the medical literature (9).
    With the advent of the Internet a whole new field of anecdotal information was emerging, connecting a variety of neurological symptoms to celiac disease. While many medical practitioners and researchers were casting aspersions on these assertions, a select few chose to explore such claims using scientific research designs and methods. While connections between stuttering and gluten consumption seem to have been overlooked by the medical research community, there is a rich literature on the Internet that cries out for more structured investigation of this connection. Conversely, perhaps a publication bias of the peer review process excludes work that explores this connection.
    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). 
    However, researchers really don’t have much data regarding the frequency and significance of clonal T cell receptor (TCR) gene rearrangements (TCR-GRs) in small bowel (SB) biopsies of patients without RCDII. Such data could provide useful comparison information for patients with RCDII, among other things.
    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. 
    They then assessed those patients and compared the results for olmesartan initiators to initiators of other ARBs after propensity score (PS) matching. They found unadjusted incidence rates of 0.82, 1.41, 1.66 and 29.20 per 1,000 person‐years for celiac disease, malabsorption, concomitant diagnoses of diarrhea and weight loss, and non‐infectious enteropathy respectively. 
    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.
    This is the first comprehensive multi‐database study to document a higher rate of enteropathy in olmesartan initiators as compared to initiators of other ARBs, though absolute rates were low for both groups.
    Source:
    Alimentary Pharmacology & Therapeutics