[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542132":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":68,"collaborators":10,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":10,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":83,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Palermo","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"FMF patients",null,"Patients, of both sexes, aged between 6 months and 80 years, affected by FMF, classified according to the Eurofever\u002FPRINTO criteria",[13,14],"Other: Main questionnaire","Other: Secondary questionnaire",{"label":16,"type":10,"description":17,"interventionNames":18},"Control subjects","Subjects of the vaccination center of the University Hospital 'Paolo Giaccone'\" of Palermo, Italy",[14],[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Main questionnaire","Main questionnaire will evaluate the demographic and genetic characteristics, clinical manifestations, and self-perception of sensitivity to wheat or other food and the possible relationship between the intake of wheat or other foods and the flare-ups of the disease in FMF patients",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Secondary questionnaire","Secondary questionnaire will investigate the possible appearance of gastrointestinal and extraintestinal symptoms linked to the ingestion of gluten\u002Fwheat, which are not identifiable, by the patient, as FMF flare-ups, but might be compatible with a NCGS\u002FNCWS diagnosis",[16,9],[29],{"name":30,"affiliation":5,"role":31},"Antonio Carroccio, MD","STUDY_DIRECTOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Pasquale Mansueto, MD","CONTACT","3477279879","pasquale.mansueto@unipa.it",{"name":39,"role":35,"phone":40,"phoneExt":10,"email":41},"Aurelio Seidita, MD","3209150370","aurelio.seidita@unipa.it",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University Hospital of Palermo","RECRUITING","Palermo","Sicily","90127","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],13.3636,38.1166,{"lat":55,"lon":54},[58,61,63,66],{"name":59,"role":35,"phone":60,"phoneExt":10,"email":37},"Pasquale Mansueto","00390916554815",{"name":59,"role":62,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":64,"role":65,"phone":10,"phoneExt":10,"email":10},"Antonio Carroccio","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":10,"phoneExt":10,"email":10},"Aurelio Seidita",{"type":62,"investigatorFullName":59,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Associate Professor","100542132","can-glutenwheat-or-other-foods-be-responsible-for-fmf-attacks-100542132",false,"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.","ALL","6 Months","80 Years",{"count":81,"type":82},60,"ESTIMATED","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.",[87,88],"Familial Mediterranean Fever","Non-celiac Gluten Sensitivity",[87,88],"2025-06-17",{"date":92,"type":93},"2025-06-22","ACTUAL",{"date":95,"type":93},"2024-05-01",{"date":97,"type":82},"2026-05-01",{"name":5,"class":6},1]