[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-celiac-gluten-sensitivity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-celiac-gluten-sensitivity":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100530795","tolerability-of-an-ancient-grain-in-patients-with-non-celiac-wheat-sensitivity-100530795",false,"NCT06191432","Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity","Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity. A Clinical Study and a Search for Diagnostic Biomarkers.","Inclusion Criteria:\n\n* age \\>18 and \\\u003C65 years;\n* 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) ;\n* absence of intestinal villous atrophy, documented in all patients carrying the DQ2 and\u002For DQ8 human leukocyte antigen haplotypes (therefore regardless of the negativity of celiac disease-specific serum antibodies);\n* absence of wheat allergy (negative prick test and\u002For serum IgE measurement specific to wheat, gluten and gliadin).\n\nExclusion Criteria:\n\n* age \\\u003C18 and \\>65 years;\n* self-exclusion of gluten\u002Fwheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;\n* pregnancy;\n* alcohol and\u002For drugs abuse;\n* Helicobacter pylori and other bacterial and\u002For parasitic infections;\n* 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;\n* cancer\n* patients undergoing chemotherapy and\u002For radiotherapy.","ALL","18 Years","65 Years",{"count":20,"type":21},68,"ESTIMATED","INTERVENTIONAL",[24],"NA","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 potential in NCWS patients. The first objective of our project is to verify whether the use of a diploid wheat (TM), with a lower concentrations and bioactivity of Amylase-Trypsin-Inhibitors (ATIs) and with gliadin proteins with a better digestibility, compared to a hexaploid one (TA) could improve both symptoms and quality of life (QoL) of NCWS subjects. The second objective is the identification of non-invasive serological biomarkers for NCWS diagnosis. The third objective is to identify T cell lymphocytes able to recognize cognate peptides from wheat proteins to better classify and monitor patients affected by NCWS. To achieve these results we planned a prospective, double-blind clinical trial with crossover, in which patients already diagnosed with NCWS (according to international criteria and with a double-blind placebo-controlled wheat challenge), following a strict WFD, will be exposed in double-blind to both TM and TA. All the patients will be evaluated clinically at the different timepoints with validated scales to assess tolerability of TM. Moreover, their intestinal permeability, immunological activation and gut microbiota patterns will be studied by both in vitro and in vivo techniques. Finally, a randomly chosen subset of patients will be studied through single cell transcriptome and T-cell receptor (TCR) sequencing on rectoscopy biopsy specimens to identify, T cell lymphocytes able to recognize cognate peptides from wheat proteins.",[27],"Non-celiac Gluten Sensitivity",[29,30,31,32],"Irritable Bowel Syndrome","Non-celiac wheat sensitivity","Triticum monococcum","Ancient grains","RECRUITING","2026-01-08",{"date":36,"type":37},"2026-01-12","ACTUAL",{"date":39,"type":37},"2024-02-01",{"date":41,"type":21},"2026-11-30",{"name":43,"class":44},"University of Palermo","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":45},"100542132","can-glutenwheat-or-other-foods-be-responsible-for-fmf-attacks-100542132","NCT06338891","Can Gluten\u002FWheat or Other Foods be Responsible for FMF Attacks","Can Gluten\u002FWheat or Other Foods be Responsible for FMF Attacks: A Survey on Self-perceived Food Sensitivity in FMF Patients","Inclusion Criteria:\n\n* Patients, of both sexes, aged between 6 months and 80 years, affected by FMF, classified according to the Eurofever\u002FPRINTO criteria.\n* Patients able to understand and complete the questionnaires independently (or, in the case of pediatric ones, analyzed through the answers provided by parents).\n\nExclusion Criteria:\n\n* Patients aged \\\u003C6 months and \\>80 years.\n* Patients unable to provide informed consent or complete the questionnaires.","6 Months","80 Years",{"count":56,"type":21},60,"1 Year","OBSERVATIONAL","Familial Mediterranean Fever (FMF) is a chronic hereditary autoinflammatory disease caused by mutations in the MEditerranean FeVer (MEFV) gene which codes for pyrin. Dysfunction of this protein determines an inappropriate response to inflammatory stimuli. The clinical course of the disease is characterized by recurrent episodes of fever and inflammation of the serous membranes, which manifest with chest, abdominal and joint pain. Several studies suggest a possible association between acute FMF attacks and dietary triggers, including wheat. However, it is still unclear to what extent wheat is responsible for the reactivation of FMF and if, between one acute attack and another, patients with FMF experience other symptoms, both gastrointestinal and extraintestinal, characteristic of gluten\u002Fwheat sensitivity not linked to celiac disease or immunoglobulin E (IgE)-mediated wheat allergy (i.e. Non-Celiac Wheat Gluten\u002FSensitivity, NCGS\u002FNCWS).\n\nTherefore, this study aims to evaluate the appearance of symptoms compatible with an acute attack of FMF following the ingestion of wheat or other foods, and the prevalence of self-perceived gluten\u002Fwheat sensitivity in patients with FMF.",[61,27],"Familial Mediterranean Fever",[61,27],"2025-06-17",{"date":65,"type":37},"2025-06-22",{"date":67,"type":37},"2024-05-01",{"date":69,"type":21},"2026-05-01",{"name":43,"class":44},"Non Celiac Gluten Sensitivity"]