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Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity

RecruitingNAAges 18 Years - 65 YearsAllUniversity of Palermo
NCT06191432 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Patients suffering from wheat-related troubles, in absence of celiac disease or wheat allergy diagnosis, can suffer from non-celiac wheat sensitivity (NCWS). This is characterized by both gastrointestinal (GI) and extra-intestinal symptoms, which improve with the elimination of wheat intake. To date no definitive explanation of pathogenetic mechanisms of NCWS has been proved, and, similarly, no specific non-invasive diagnostic biomarker has been recognized. A real need of strict adherence to wheat-free diet (WFD) in NCWS has never been demonstrated. In this context, research is actively trying to find wheat varieties with absent or low immune-reactivity to be used for the treatment of NCWS patients. Preliminary evidence supports the assumption that diploid wheat species, as Triticum monococcum (TM), compared to common ones (Triticum aestivum (TA), could possess a lower immunogenic potent

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📋 Eligibility rules (as published)
Inclusion Criteria: * age \>18 and \<65 years; * negativity of class A (IgA) and G (IgG) immunoglobulin (Ig) anti-deamidated gliadin (anti-DGP); negativity of IgA and IgG anti-tissue transglutaminase (anti-tTG) and anti-endomysial antibodies (EMA) ; * absence of intestinal villous atrophy, documented in all patients carrying the DQ2 and/or DQ8 human leukocyte antigen haplotypes (therefore regardless of the negativity of celiac disease-specific serum antibodies); * absence of wheat allergy (negative prick test and/or serum IgE measurement specific to wheat, gluten and gliadin). Exclusion Criteria: * age \<18 and \>65 years; * self-exclusion of gluten/wheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study; * pregnancy; * alcohol and/or drugs abuse; * Helicobacter pylori and other bacterial and/or parasitic infections; * diagnosis of chronic inflammatory intestinal diseases and other organic pathologies affecting the digestive system (for example, serious liver diseases), nervous system diseases, major psychiatric disorders, immunological deficits and impairments that limit physical activity; * cancer * patients undergoing chemotherapy and/or radiotherapy.
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What it tests

  • Administration of Triticum Monococcum flour
  • Administration of Triticum Aestivum flour
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Where

1 site
University Hospital of Palermo
Palermo, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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