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/32316660Actively Recruiting
Led by University of Palermo · Updated on 2025-06-22
60
Participants Needed
1
Research Sites
87 weeks
Total Duration
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
Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
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
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
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
Total: 1 location
1
University Hospital of Palermo
Palermo, Sicily, Italy, 90127
Actively Recruiting
P
Pasquale Mansueto, MD
A
Aurelio Seidita, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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