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Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity

RecruitingNAAges 18 Years - 65 YearsAllUniversity of Palermo
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In plain words

What the trial is, and whether it could suit you

Non-celiac gluten sensitivity (NCGS) is a condition where intestinal and extraintestinal symptoms are triggered by gluten ingestion in the absence of celiac disease and wheat allergy. Despite the great interest in NCGS, much remains unknown about the pathogenesis. Some studies seem to suggest that wheat components other than gluten (i.e. amylase/trypsine inhibitors, ATIs) can cause the symptoms, and therefore the term "non-celiac wheat sensitivity" (NCWS) has been proposed instead of NCGS. It is believed that this condition is worldwide increasing, due to the evolution of wheat breeding (i.e. consumption of wheats with high gluten content), and that ancient wheats are better tolerated by NCWS patients than the modern ones. Therefore, the aim of the study is to determine whether the common belief regarding the fact that ancient wheats are better tolerated by NCWS patients than the modern

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: All the patients will meet the recently proposed criteria: * negative serum anti-tissue transglutaminase and antiendomysium (EmA) immunoglobulin (Ig)A and IgG antibodies * absence of intestinal villous atrophy * IgE-mediated immunoallergic tests negative to wheat (skin prick tests and/or serum specific IgE detection) * follow-up duration \>12 months after the initial diagnosis * at least two outpatient visits during the follow-up period. Adjunctive criteria adopted in our patients will be: * resolution of the gastrointestinal symptoms on a standard elimination diet, without wheat, cow's milk, egg, tomato, chocolate, or other food(s) causing self-reported symptoms * symptom reappearance on DBPC wheat challenge, performed as described previously. As in previous studies, DBPC cow's milk protein challenge and other "open" food challenges will be also performed. Exclusion Criteria: Exclusion criteria will be: * age \<18 years * positive EmA in the culture medium of the duodenal biopsies, even if the villi to crypts ratio in the duodenal mucosa was normal * self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study * other organic gastrointestinal diseases (i.e. careful exclusion of Crohn's disease) * concomitant treatment with steroids and/or antihistamines.
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What it tests

  • Wheat flour
  • Placebo
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Where

2 sites
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
Sciacca, Italy
Department of Internal Medicine, University Hospital of Palermo
Palermo, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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