Investigating the Role of Foods in Familial Mediterranean Fever Attacks
Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks: A Survey on Self-perceived Food Sensitivity in FMF Patients
This study is trying to see if certain foods, like gluten and wheat, can trigger or worsen attacks in people with Familial Mediterranean Fever.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 6 Months to 80 Years |
| Sex | All |
| Sponsor | University of Palermo Academic / other |
| Locations | 1 site (Palermo, Sicily) |
| Trial ID | NCT06338891 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the potential relationship between dietary triggers, particularly gluten and wheat, and the exacerbation of Familial Mediterranean Fever (FMF) attacks. It will involve patients diagnosed with FMF who will complete questionnaires to assess their dietary habits and any associated symptoms. The study seeks to clarify whether certain foods contribute to the frequency or severity of FMF episodes, which could lead to better dietary recommendations for affected individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged between 6 months and 80 years diagnosed with Familial Mediterranean Fever.
Not a fit: Patients outside the age range of 6 months to 80 years or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify dietary triggers for FMF attacks, leading to improved management and quality of life for patients.
How similar studies have performed: While some studies have explored dietary influences on FMF, the specific focus on gluten and wheat as triggers is less established, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Palermo, Sicily
- University Hospital of Palermo — Palermo, Sicily, Italy (Recruiting)
Study contacts
- Study coordinator: Pasquale Mansueto, MD
- Email: pasquale.mansueto@unipa.it
- Phone: 3477279879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.