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NCWS or IBS/FD in Relatives of CD Patients

RecruitingNAAges 18 Years - anyAllUniversity of Palermo
NCT07584473 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Over 50% of non-celiac wheat sensitivity (NCWS) patients are HLA DQ2/DQ8 positive and often have a Celiac Disease (CD) family history. Studies have identified a subgroup of NCWS patients whose clinical and immunological features are closer to CD than to irritable bowel syndrome/functional dyspepsia (IBS/FD) ('inflammatory subgroup'). The investigators hypothesized that among CD patient's relatives, there might be a high number of NCWS subjects, who hypothetically belong to the 'inflammatory subgroup'. Therefore, the aim of this multi-step project is to identify the prevalence of both self-reported NCWS and IBS/FD not related to wheat ingestion among CD patient's relatives (parents, grandparents, siblings and sons).

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📋 Eligibility rules (as published)
Inclusion criteria * CD patient's relatives * \>18 years old * reporting IBS/FD-like and extraintestinal (EI) symptoms Exclusion criteria * self-exclusion of wheat from the diet and refuse to reintroduce it for diagnostic purposes; * drug and/or alcohol (\>30 g/day for men and \>20 g/day for women) abuse; * treatment with steroids and/or non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy; * pregnancy or breastfeeding; * diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system \[e.g., IgE-mediated Wheat Allergy (WA), microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.\], neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity.
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What it tests

  • Wheat-Free Diet
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Where

2 sites
Celiac Disease and Food Intolerance Clinic, Geriatrics Unit, "P. Giaccone" University Hospital, Palermo
Palermo, Italy
Internal Medicine Unit, P.O. "V. Cervello," Ospedali Riuniti "Villa Sofia-Cervello," Palermo
Palermo, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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