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Search / Trial NCT03563300

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.

Locations

Sciacca, Agrigento, Italy

Palermo, , Italy

Patients applied

0 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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