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Study identifier: NCT06338891 Synced from ClinicalTrials.gov · July 29, 2026
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Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks

Condition: Familial Mediterranean Fever · Non-celiac Gluten Sensitivity  ·  Sponsor: University of Palermo

PhaseN/A
Planned participants60
Who can joinAll sexes, 6 Months to 80 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Pasquale Mansueto, MD  ·  3477279879  ·  pasquale.mansueto@unipa.it

Aurelio Seidita, MD  ·  3209150370  ·  aurelio.seidita@unipa.it

Always discuss trial participation with your own doctor first.

Locations (1)

University Hospital of PalermoPalermo, Sicily, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06338891