Actively Recruiting

Age: 6Months - 80Years
All Genders
ID06338891

Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks: A Survey on Self-perceived Food Sensitivity in FMF Patients

Led by University of Palermo · Updated on 2025-06-22

60

Participants Needed

1

Research Sites

87 weeks

Total Duration

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AI-Summary

What this Trial Is About

Familial Mediterranean Fever (FMF) is a hereditary autoinflammatory disease caused by mutations in the MEFV gene, leading to inappropriate inflammatory responses. FMF causes recurrent episodes of fever and inflammation, with symptoms like chest, abdominal, and joint pain. Researchers are studying the possible link between FMF attacks and dietary triggers such as wheat, as well as symptoms related to gluten/wheat sensitivity not linked to celiac disease or wheat allergy, called Non-Celiac Wheat Gluten/Sensitivity (NCGS/NCWS). The study involves FMF patients and control subjects who will complete questionnaires to evaluate their demographics, genetics, clinical symptoms, and self-perceived sensitivity to wheat or other foods. The questionnaires will assess whether ingestion of wheat or other foods triggers FMF attacks or causes gastrointestinal and extraintestinal symptoms compatible with NCGS/NCWS. The study will compare differences between FMF patients with and without these food-related triggers. Participants will be asked to complete questionnaires about their symptoms and food sensitivities. Researchers will assess the prevalence of self-perceived wheat or food triggers for FMF attacks and NCGS/NCWS symptoms. They will also analyze genetic, clinical, and demographic differences among patients based on these self-reports. The study will run from May 2024 to May 2025, focusing on these outcomes to better understand the relationship between diet and FMF flare-ups.

CONDITIONS

Brief Title

Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks

Who Can Participate

Age: 6Months - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of both sexes aged between 6 months and 80 years
  • Diagnosed with Familial Mediterranean Fever (FMF) according to Eurofever/PRINTO criteria
  • Able to understand and complete questionnaires independently or with parental help if pediatric
Not Eligible

You will not qualify if you...

  • Patients younger than 6 months or older than 80 years
  • Unable to provide informed consent or complete questionnaires independently

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) to confirm eligibility and explain questionnaires

Survey Completion

Duration - Approximately 1 to 2 weeks

Participants complete questionnaires about demographic and genetic characteristics, clinical symptoms, and self-perceived sensitivity to wheat or other foods and their possible role in triggering FMF attacks.

1 to 2 visits or remote sessions to complete main and secondary questionnaires

Observational Monitoring

Duration - Up to 1 year

Participants' responses are observed and analyzed to assess the relationship between food intake and FMF flare-ups over the study period.

No additional visits required; ongoing observation based on questionnaire responses

Trial Site Locations

Total: 1 location

1

University Hospital of Palermo

Palermo, Sicily, Italy, 90127

Actively Recruiting

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Research Team

P

Pasquale Mansueto, MD

A

Aurelio Seidita, MD

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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Published Research Related To This Trial

Wheat Consumption Leads to Immune Activation and Symptom Worsening in Patients with Familial Mediterranean Fever: A Pilot Randomized Trial.

Antonio Carroccio, Pasquale Mansueto, Maurizio Soresi...

https://pubmed.ncbi.nlm.nih.gov/32316660

The contribution of diet preference to the disease course in children with familial Mediterranean fever: a cross-sectional study.

Rabia Miray Kisla Ekinci, Sibel Balci, Atıl Bisgin...

https://pubmed.ncbi.nlm.nih.gov/32476680

A New Proposal for the Pathogenic Mechanism of Non-Coeliac/Non-Allergic Gluten/Wheat Sensitivity: Piecing Together the Puzzle of Recent Scientific Evidence.

Valentina Leccioli, Mara Oliveri, Marcello Romeo...

https://pubmed.ncbi.nlm.nih.gov/29099090