NCT06338891 Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
| NCT ID | NCT06338891 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Palermo |
| Condition | Familial Mediterranean Fever |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2024-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-05-01 with a primary completion date of 2024-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Antonio Carroccio, MD
STUDY DIRECTOR
University of Palermo
Frequently Asked Questions
Who can join the NCT06338891 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 80 Years, studying Familial Mediterranean Fever. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06338891 currently recruiting?
Yes, NCT06338891 is actively recruiting participants. Contact the research team at pasquale.mansueto@unipa.it for enrollment information.
Where is the NCT06338891 trial being conducted?
This trial is being conducted at Palermo, Italy.
Who is sponsoring the NCT06338891 clinical trial?
NCT06338891 is sponsored by University of Palermo. The principal investigator is Antonio Carroccio, MD at University of Palermo. The trial plans to enroll 60 participants.