NCWS or IBS/FD in Relatives of CD Patients
University of Palermo
600 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria3
- CD patient's relatives
- >18 years old
- reporting IBS/FD-like and extraintestinal (EI) symptoms
Exclusion Criteria5
- 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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Interventions
Patients, identified at T1, will undergo a 6-week long strict WFD (preliminary dietician consul will be granted to all subjects), at the end of which (T2) they will fill-out an online form including a WFD adherence questionnaire (i.e. modified 'Biagi' score) and the questionnaires reported in WP1. Patients reporting a reduction ≥30% in at least one questionnaire after WFD will be identified as self-reported NCWS, all the others will be identified as IBS/FD not related to wheat intake.
Locations(2)
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NCT07584473