protocolSection identificationModule nctId: NCT06338891, orgStudyIdInfo id: ACPM34, briefTitle: Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, descriptionModule briefSummary: 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/wheat sensitivity not linked to celiac disease or immunoglobulin E (IgE)-mediated wheat allergy (i.e. Non-Celiac Wheat Gluten/Sensitivity, NCGS/NCWS).Therefore, 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/wheat sensitivity in patients with FMF., conditionsModule conditions: Familial Mediterranean Fever, conditions: Non-celiac Gluten Sensitivity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Main questionnaire, interventions name: Secondary questionnaire, outcomesModule primaryOutcomes measure: Prevalence of the self-perception of wheat as a potential trigger of acute attack in patients with familial Mediterranean fever (FMF), primaryOutcomes measure: Prevalence of the self-perception of other foods, other than wheat, as potential triggers of an acute attack in patients with FMF, primaryOutcomes measure: Prevalence of self-reported NCGS/NCWS in patients with FMF, secondaryOutcomes measure: Genetic differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Genetic differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Genetic differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Ethnic group differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Ethnic group differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Ethnic group differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Education level differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Education level differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Education level differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Working activity differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Working activity differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Working activity differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Gastrointestinal symptoms differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Gastrointestinal symptoms differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Gastrointestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Extraintestinal symptoms differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Extraintestinal symptoms differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Extraintestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Extraintestinal symptoms duration differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Extraintestinal symptoms duration differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Extraintestinal symptoms duration between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Gastrointestinal symptoms duration differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Gastrointestinal symptoms duration differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Gastrointestinal symptoms duration differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: FMF specific drugs intake differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: FMF specific drugs intake differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: FMF specific drugs intake differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Differences in number/year of FMF attacks between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Differences in number/year of FMF attacks between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Differences in number/year of FMF attacks between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Differences in FMF specific drugs intake adherence between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Differences in FMF specific drugs intake adherence between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Differences in FMF specific drugs intake adherence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Differences in marital status between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Differences in marital status between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Differences in marital status between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Differences in age at FMF diagnosis between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Differences in age at FMF diagnosis between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Differences in age at FMF diagnosis between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., secondaryOutcomes measure: Differences in age at FMF symptom's onset between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares., secondaryOutcomes measure: Differences in age at FMF symptom's onset between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares., secondaryOutcomes measure: Differences in age at FMF symptom's onset between patients with FMF who self-report NCGS/NCWS and those who do not self-report it., eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Palermo, status: RECRUITING, city: Palermo, state: Sicily, zip: 90127, country: Italy, contacts name: Pasquale Mansueto, role: CONTACT, phone: 00390916554815, email: pasquale.mansueto@unipa.it, contacts name: Pasquale Mansueto, role: PRINCIPAL_INVESTIGATOR, contacts name: Antonio Carroccio, role: SUB_INVESTIGATOR, contacts name: Aurelio Seidita, role: SUB_INVESTIGATOR, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False