Actively Recruiting
Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
Led by University of Palermo · Updated on 2025-06-22
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of both sexes aged between 6 months and 80 years with a diagnosis of FMF according to Eurofever/PRINTO criteria
- Patients who can understand and complete the questionnaires independently or with parental help for children
You will not qualify if you...
- Patients younger than 6 months or older than 80 years
- Patients unable to provide informed consent or complete the questionnaires
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Palermo
Palermo, Sicily, Italy, 90127
Actively Recruiting
Research Team
P
Pasquale Mansueto, MD
CONTACT
A
Aurelio Seidita, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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