Familial Mediterranean Fever Clinical Trial
Official title:
Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks: A Survey on Self-perceived Food Sensitivity in FMF Patients
NCT number | NCT06338891 |
Other study ID # | ACPM34 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2024 |
Est. completion date | May 1, 2025 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 1, 2025 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 80 Years |
Eligibility | Inclusion Criteria: - Patients, of both sexes, aged between 6 months and 80 years, affected by FMF, classified according to the Eurofever/PRINTO criteria. - Patients able to understand and complete the questionnaires independently (or, in the case of pediatric ones, analyzed through the answers provided by parents). Exclusion Criteria: - Patients aged <6 months and >80 years. - Patients unable to provide informed consent or complete the questionnaires. |
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital of Palermo | Palermo | Sicily |
Lead Sponsor | Collaborator |
---|---|
University of Palermo |
Italy,
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Demir A, Akyuz F, Gokturk S, Evirgen S, Akyuz U, Ormeci A, Soyer O, Karaca C, Demir K, Gundogdu G, Gulluoglu M, Erer B, Kamali S, Kaymakoglu S, Besisik F, Gul A. Small bowel mucosal damage in familial Mediterranean fever: results of capsule endoscopy scre — View Citation
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Leccioli V, Oliveri M, Romeo M, Berretta M, Rossi P. A New Proposal for the Pathogenic Mechanism of Non-Coeliac/Non-Allergic Gluten/Wheat Sensitivity: Piecing Together the Puzzle of Recent Scientific Evidence. Nutrients. 2017 Nov 2;9(11):1203. doi: 10.339 — View Citation
Mansueto P, Seidita A, Chiavetta M, Genovese D, Giuliano A, Priano W, Carroccio A, Casuccio A, Amodio E. Familial Mediterranean Fever and Diet: A Narrative Review of the Scientific Literature. Nutrients. 2022 Aug 5;14(15):3216. doi: 10.3390/nu14153216. — View Citation
Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996. — View Citation
MELLINKOFF SM, SCHWABE AD, LAWRENCE JS. A dietary treatment for familial Mediterranean fever. Arch Intern Med. 1961 Jul;108:80-5. doi: 10.1001/archinte.1961.03620070082010. No abstract available. — View Citation
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Uhde M, Ajamian M, Caio G, De Giorgio R, Indart A, Green PH, Verna EC, Volta U, Alaedini A. Intestinal cell damage and systemic immune activation in individuals reporting sensitivity to wheat in the absence of coeliac disease. Gut. 2016 Dec;65(12):1930-19 — View Citation
Verrecchia E, Sicignano LL, La Regina M, Nucera G, Patisso I, Cerrito L, Montalto M, Gasbarrini A, Manna R. Small Intestinal Bacterial Overgrowth Affects the Responsiveness to Colchicine in Familial Mediterranean Fever. Mediators Inflamm. 2017;2017:746142 — View Citation
Yenokyan G, Armenian HK. Triggers for attacks in familial Mediterranean fever: application of the case-crossover design. Am J Epidemiol. 2012 May 15;175(10):1054-61. doi: 10.1093/aje/kwr460. Epub 2012 Jan 10. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of the self-perception of wheat as a potential trigger of acute attack in patients with familial Mediterranean fever (FMF) | To determine the prevalence of the self-perception of wheat as a potential trigger of acute attack in patients with FMF, defined as the appearance of symptoms and signs compatible with FMF flare-up following wheat intake. | From May 2024 to May 2025 | |
Primary | Prevalence of the self-perception of other foods, other than wheat, as potential triggers of an acute attack in patients with FMF | To determine the prevalence of the self-perception of other foods, other than wheat, as potential triggers of an acute attack in patients with FMF, defined as the appearance of symptoms and signs compatible with a flare-up of FMF following the intake of these specific foods, other than wheat. | From May 2024 to May 2025 | |
Primary | Prevalence of self-reported NCGS/NCWS in patients with FMF | To determine the prevalence of self-reported NCGS/NCWS in patients with FMF, defined as the appearance of gastrointestinal and extraintestinal symptoms and signs secondary to gluten/wheat ingestion, compatible with the clinical manifestations of NCGS/NCWS and not identifiable, by the patient, as FMF flare-ups, compared to a control group. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in prevalence in the specific genetic mutations related to FMF 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in prevalence in the specific genetic mutations related to FMF 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Genetic differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in prevalence in the specific genetic mutations related to FMF between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in ethnic group prevalence 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in ethnic group prevalence 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Ethnic group differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in ethnic group prevalence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in education level prevalence 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in education level prevalence 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Education level differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in education level prevalence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in working activity 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in working activity 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Working activity differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in working activity between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in gastrointestinal symptoms prevalence 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in gastrointestinal symptoms prevalence 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Gastrointestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in gastrointestinal symptoms prevalence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in extraintestinal symptoms prevalence 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in extraintestinal symptoms prevalence 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Extraintestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in extraintestinal symptoms prevalence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in extraintestinal symptoms duration 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in extraintestinal symptoms duration 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Extraintestinal symptoms duration between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in extraintestinal symptoms duration between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in gastrointestinal symptoms duration 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in gastrointestinal symptoms duration 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Gastrointestinal symptoms duration differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in gastrointestinal symptoms duration between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in FMF specific drugs intake 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in FMF specific drugs intake 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | FMF specific drugs intake differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in FMF specific drugs intake between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Differences in number/year of FMF attacks between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in number/year of FMF attacks between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Differences in FMF specific drugs intake adherence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in FMF specific drugs intake adherence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in marital status prevalence 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in marital status prevalence 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Differences in marital status between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in marital status prevalence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | Differences in age at FMF diagnosis between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. | To define any difference in age at FMF diagnosis between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference 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. The data will be collected through the answers provided to the questions in the main questionnaire. | From May 2024 to May 2025 | |
Secondary | 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. | To define any difference in age at FMF symptom's onset between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. The data will be collected through the answers provided to the questions in the secondary questionnaire. | From May 2024 to May 2025 |
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