Investigating the Role of Foods in Familial Mediterranean Fever Attacks
Official title: Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks: A Survey on Self-perceived Food Sensitivity in FMF Patients
Run by University of Palermo · NCT06338891 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 6 Months to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Palermo Academic / other |
| Locations | 1 site (Palermo, Sicily) |
| Status | Recruiting |
| Started | May 1, 2024 |
| Main results expected | August 30, 2024 |
| Study ends | May 1, 2026 |
| Registry record updated | June 22, 2025 |
| Trial ID | NCT06338891 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged between 6 months and 80 years diagnosed with Familial Mediterranean Fever.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
University Hospital of Palermo
Palermo, Sicily, Italy Recruiting
Study contacts
- Study coordinator: Pasquale Mansueto, MD
- Email: pasquale.mansueto@unipa.it
- Phone: 3477279879
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Canakinumab use in FMF and Still's disease patients across real-world care
This real-world study looks at how people with FMF or Still's disease who were treated with canakinumab fare over at least 6 months.
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Mediterranean diet with or without aerobic exercise for women with familial Mediterranean fever and fatty liver
This trial will test whether adding regular aerobic exercise to a Mediterranean diet helps women with familial Mediterranean fever who have non-alcoholic fatty liver disease.
-
Whole-body vibration plus vitamin D for adolescent girls with familial Mediterranean fever
This project will try adding regular whole-body vibration sessions to vitamin D and usual colchicine for girls aged 13–17 with familial Mediterranean fever to see if it improves fitness, muscle strength, and bone mass.
-
Inspiratory muscle training for adolescents with Familial Mediterranean Fever
This trial will try a daily inspiratory muscle training program to see if it improves breathing strength, exercise tolerance, and fatigue in teenagers (ages 13–17) with Familial Mediterranean Fever who are taking colchicine.
-
Testing an ancient grain for patients with non-celiac wheat sensitivity
This study is testing if an ancient grain called Triticum monococcum is easier for people with non-celiac wheat sensitivity to tolerate compared to regular wheat.
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Using RPH-104 to prevent fever attacks in patients with Familial Mediterranean Fever who can't tolerate colchicine
This study is testing if RPH-104 can help adults with Familial Mediterranean Fever who can’t take colchicine by preventing their fever attacks over a long period.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.