[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100287676":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":43,"locations":51,"responsibleParty":81,"collaborators":34,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":34,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":34,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":54,"whyStopped":34,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Palermo","OTHER",[8,14,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Comparator 1","ACTIVE_COMPARATOR","Wheat flour with high inflammatory response will be administered blindly versus placebo for 15 days in NCWS patients.",[13],"Dietary Supplement: Wheat flour",{"label":15,"type":10,"description":16,"interventionNames":17},"Active Comparator 2","Wheat flour with low inflammatory response will be administered blindly versus placebo for 15 days in NCWS patients.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo 1","PLACEBO_COMPARATOR","Placebo (xylose) will be administered blindly versus wheat flour with high inflammatory response for 15 days in NCWS patients.",[23],"Dietary Supplement: Placebo",{"label":25,"type":20,"description":26,"interventionNames":27},"Placebo 2","Placebo (xylose) will be administered blindly versus wheat flour with low inflammatory response for 15 days in NCWS patients.",[23],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DIETARY_SUPPLEMENT","Wheat flour","Wheat flour will be administered three times per day for 15 days.",[9,15],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Placebo","Placebo (xylose) will be administered three times per day for 15 days.",[19,25],[40],{"name":41,"affiliation":5,"role":42},"Antonio Carroccio, PhD","STUDY_DIRECTOR",[44,48],{"name":41,"role":45,"phone":46,"phoneExt":34,"email":47},"CONTACT","+390916552884","acarroccio@hotmail.com",{"name":49,"role":45,"phone":46,"phoneExt":34,"email":50},"Pasquale Mansueto, MD","pasquale.mansueto@unipa.it",[52,70],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca","RECRUITING","Sciacca","Agrigento","92019","Italy","IT",{"type":61,"coordinates":62},"Point",[63,64],13.08399,37.50693,{"lat":64,"lon":63},[67],{"name":68,"role":45,"phone":69,"phoneExt":34,"email":47},"Antonio Carroccio, MD, PhD","+390916554347",{"facility":71,"status":54,"city":72,"state":72,"zip":73,"country":58,"countryCode":59,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Department of Internal Medicine, University Hospital of Palermo","Palermo","90129",{"type":61,"coordinates":75},[76,77],13.3636,38.1166,{"lat":77,"lon":76},[80],{"name":49,"role":45,"phone":69,"phoneExt":34,"email":50},{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Pasquale Mansueto","MD","100287676","response-to-different-wheat-genotypes-in-not-celiac-wheat-sensitivity-100287676",false,"NCT03024775","Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity","Clinical Response and Cytokines Production After Challenge With Different Wheat Genotypes in Patients With Not-celiac Wheat Sensitivity.","Inclusion Criteria:\n\nAll the patients will meet the recently proposed criteria:\n\n* negative serum anti-tissue transglutaminase and antiendomysium (EmA) immunoglobulin (Ig)A and IgG antibodies\n* absence of intestinal villous atrophy\n* IgE-mediated immunoallergic tests negative to wheat (skin prick tests and\u002For serum specific IgE detection)\n* follow-up duration \\>12 months after the initial diagnosis\n* at least two outpatient visits during the follow-up period.\n\nAdjunctive criteria adopted in our patients will be:\n\n* 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\n* 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.\n\nExclusion Criteria:\n\nExclusion criteria will be:\n\n* age \\\u003C18 years\n* positive EmA in the culture medium of the duodenal biopsies, even if the villi to crypts ratio in the duodenal mucosa was normal\n* self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study\n* other organic gastrointestinal diseases (i.e. careful exclusion of Crohn's disease)\n* concomitant treatment with steroids and\u002For antihistamines.","ALL","18 Years","65 Years",{"count":96,"type":97},50,"ESTIMATED","INTERVENTIONAL",[100],"NA","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\u002Ftrypsine 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 ones is confirmed by scientific data, and to identify the wheat kernel components triggering this pathology. The availability of wheat materials with opposite characteristics, such as the period of development (ancient vs. modern), or the technological properties (cultivars with weak glutens vs. strong gluten), or the presence\u002Fabsence of specific ATIs polypeptides, will allow to define the role played by these factors. Therefore, the study has two objectives: 1) extraction and testing of total kernel proteins, in order to evaluate the inflammatory response to gluten and non-gluten proteins by peripheral blood mononuclear cells (PBMC) and immunocytes extracted by the rectal mucosa of NCWS patients and healthy control subjects, and 2) clinically testing two wheat genotypes, selected on the basis of the previous in vitro studies, showing the highest and the lowest in vitro inflammatory response, in order to verify their effect in triggering NCWS symptoms.",[103],"Non-celiac Wheat Sensitivity",[103,105,106,107],"ancient wheats","modern wheats","ATIs","2025-06-17",{"date":110,"type":111},"2025-06-22","ACTUAL",{"date":113,"type":111},"2017-01-01",{"date":115,"type":97},"2026-12-01",{"name":5,"class":6},2]