[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639939":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":63,"collaborators":30,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":30,"eligibilityCriteria":71,"healthyVolunteers":68,"sex":72,"minAge":73,"maxAge":30,"enrollmentInfo":74,"targetDuration":30,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":38,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Palermo","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Six-week long strict Wheat-Free Diet","ACTIVE_COMPARATOR","CD patient's first-degree relatives with IBS\u002FFD-like and extraintestinal (EI) symptoms",[13],"Other: Wheat-Free Diet",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Wheat-Free Diet","Patients, identified at T1, will undergo a 6-week long strict WFD (preliminary dietician consul will be granted to all subjects), at the end of which (T2) they will fill-out an online form including a WFD adherence questionnaire (i.e. modified 'Biagi' score) and the questionnaires reported in WP1. Patients reporting a reduction ≥30% in at least one questionnaire after WFD will be identified as self-reported NCWS, all the others will be identified as IBS\u002FFD not related to wheat intake.",[9],[20],"WFD",[22],{"name":23,"affiliation":5,"role":24},"Antonio Carroccio, MD","STUDY_DIRECTOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Pasquale Mansueto, MD","CONTACT","+393477279879",null,"pasquale.mansueto@unipa.it",{"name":33,"role":28,"phone":30,"phoneExt":30,"email":34},"Aurelio Seidita, MD","aurelio.seidita@unipa.it",[36,55],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Celiac Disease and Food Intolerance Clinic, Geriatrics Unit, \"P. Giaccone\" University Hospital, Palermo","RECRUITING","Palermo","PA","90127","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],13.3636,38.1166,{"lat":48,"lon":47},[51],{"name":52,"role":28,"phone":53,"phoneExt":30,"email":54},"Pasquale Mansueto","3477279879","pamansueto@gmail.com",{"facility":56,"status":38,"city":39,"state":40,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Internal Medicine Unit, P.O. \"V. Cervello,\" Ospedali Riuniti \"Villa Sofia-Cervello,\" Palermo","90146",{"type":45,"coordinates":59},[47,48],{"lat":48,"lon":47},[62],{"name":52,"role":28,"phone":53,"phoneExt":30,"email":54},{"type":64,"investigatorFullName":52,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100639939","ncws-or-ibsfd-in-relatives-of-cd-patients-100639939",false,"NCT07584473","NCWS or IBS\u002FFD in Relatives of CD Patients","Inclusion criteria\n\n* CD patient's relatives\n* \\>18 years old\n* reporting IBS\u002FFD-like and extraintestinal (EI) symptoms\n\nExclusion criteria\n\n* self-exclusion of wheat from the diet and refuse to reintroduce it for diagnostic purposes;\n* drug and\u002For alcohol (\\>30 g\u002Fday for men and \\>20 g\u002Fday for women) abuse;\n* treatment with steroids and\u002For non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy;\n* pregnancy or breastfeeding;\n* diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system \\[e.g., IgE-mediated Wheat Allergy (WA), microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.\\], neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity.","ALL","18 Years",{"count":75,"type":76},600,"ESTIMATED","INTERVENTIONAL",[79],"NA","Over 50% of non-celiac wheat sensitivity (NCWS) patients are HLA DQ2\u002FDQ8 positive and often have a Celiac Disease (CD) family history. Studies have identified a subgroup of NCWS patients whose clinical and immunological features are closer to CD than to irritable bowel syndrome\u002Ffunctional dyspepsia (IBS\u002FFD) ('inflammatory subgroup'). The investigators hypothesized that among CD patient's relatives, there might be a high number of NCWS subjects, who hypothetically belong to the 'inflammatory subgroup'. Therefore, the aim of this multi-step project is to identify the prevalence of both self-reported NCWS and IBS\u002FFD not related to wheat ingestion among CD patient's relatives (parents, grandparents, siblings and sons).",[82,83,84,85],"Non Celiac Wheat Sensitivity","IBS (Irritable Bowel Syndrome)","Functional Dyspepsia","Celiac Disease",[87,88,89,90,91],"non celiac wheat sensitivity","irritable bowel syndrome","functional dyspepsia","celiac disease","Relatives","2026-05-07",{"date":94,"type":95},"2026-05-13","ACTUAL",{"date":97,"type":95},"2026-04-01",{"date":99,"type":76},"2028-04-30",{"name":5,"class":6},2]