Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-80
SponsorUniversity of Palermo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Patients aged <6 months and >80 years.
Patients unable to provide informed consent or complete the questionnaires.
Trial population
Patients with a diagnosis of FMF will be enrolled in four Italian centers: the "Ambulatorio di Celiachia ed Intolleranze Alimentari" of "Azienda Ospedaliera Universitaria Policlinico (AOUP) 'Paolo Giaccone'", Palermo, Italy, the Internal Medicine Unit of "Azienda Ospedaliera 'Ospedali Riuniti Villa Sofia-Cervello'", Palermo, Italy, the "Centro di Riferimento per le Malattie Autoinfiammatorie e per le Malattie Lisosomiali" and the "Unità Malattie Rare, Centro Ricerca sulle Febbri Periodiche" of "Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS", Rome, Italy. Patients will be asked to reposnd to a main questionnaire, to evaluate the patient's demographic, clinical and genetic characteristics, and the perception of a link between FMF exacerbations and intake of wheat or other foods, and, in patients with self-reported NCGS/NCWS, gastrointestinal and extraintestinal manifestations related to gluten/wheat intake will be investigated using a further secondary questionnaire.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Main questionnaire
Other interventionMain 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
Secondary questionnaire
Other interventionSecondary questionnaire will investigate the possible appearance of gastrointestinal and extraintestinal symptoms linked to the ingestion of gluten/wheat, which are not identifiable, by the patient, as FMF flare-ups, but might be compatible with a NCGS/NCWS diagnosis
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: FMF patients2 interventions
Group B: Control subjects1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From May 2024 to May 20252
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.
Time frame
From May 2024 to May 20253
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.
Time frame
From May 2024 to May 2025Secondary outcomes
1
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.
Time frame
From May 2024 to May 20252
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.
Time frame
From May 2024 to May 20253
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.
Time frame
From May 2024 to May 20254
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.
Time frame
From May 2024 to May 2025Sponsors and contacts
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Source ClinicalTrials.gov