Gluten-related Disorders in Familial Mediterranean Fever Patients
Launched by UNIVERSITY OF PALERMO · Jun 19, 2018
Trial Information
Current as of May 27, 2025
Completed
Keywords
ClinConnect Summary
It is known that the gluten-containing grains can be responsible for human diseases related to gluten exposure. These forms of gluten intolerance represent a heterogeneous set of conditions, including celiac disease (CD), wheat allergy (WA) and not celiac gluten sensitivity (NCGS), that combined seems to affect about 5-10% of the general population. NCGS is the most recent gluten-related disease. It is characterized by intestinal (i.e. irritable bowel syndrome, bloating, dyspepsia) and extra-intestinal symptoms (i.e. fatigue, headache, numbness, mental confusion) related to the ingestion of...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patients, both genders, with age between 18-65 years, affected with FMF, diagnosed according to clinical criteria designed by Livneh et al ("Tel-Hashomer" criteria), self-reporting a relationship between their symptoms (especially gastrointestinal) and gluten assumption, improving on a gluten-free diet and worsen on a gluten containing diet
- • Patients testing negative for celiac disease (anti-tTG and EMA negative, and with biopsy Marsh 0-1) and wheat allergy (serum specific IgE for wheat negative)
- Exclusion Criteria:
- • Subjects diagnosed with celiac disease (positive anti-tTG and/or EMA, and positive histology, with Marsh 2 or above);
- • Subjects diagnosed with wheat allergy (positive serum specific IgE for wheat)
- • Subjects with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis)
- • Subjects with Helicobacter pylori infection and other gastrointestinal infection
- • Pregnancy
About University Of Palermo
The University of Palermo, a distinguished institution located in Italy, is dedicated to advancing medical research and education through innovative clinical trials. Renowned for its commitment to scientific excellence, the university leverages its multidisciplinary expertise and state-of-the-art facilities to conduct research that addresses critical healthcare challenges. By fostering collaborations with leading researchers and healthcare professionals, the University of Palermo aims to translate scientific findings into effective therapies, ultimately contributing to improved patient outcomes and public health advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sciacca, Agrigento, Italy
Palermo, , Italy
Patients applied
Trial Officials
Antonio Carroccio, PhD
Principal Investigator
University of Palermo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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