Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
Recruiting now
Conditions studied: Familial Mediterranean Fever, Non-celiac Gluten Sensitivity
In brief
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.
Key facts
- Study ID
- NCT06338891
- Run by
- University of Palermo
- People needed
- 60
- Starts
- 2024-05-01
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2025-06-22
Who can join
Age: 1 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- Patients aged <6 months and >80 years.
- Patients unable to provide informed consent or complete the questionnaires.
Where it is running
- University Hospital of Palermo — Palermo, Sicily, Italy (enrolling)
Full record on ClinicalTrials.gov
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