NCWS or IBS/FD in Relatives of CD Patients
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- Who runs it
- University of Palermo
- Trial code
- NCT07584473
- Record updated
- 13 May 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: CD patient's relatives; >18 years old; reporting IBS/FD-like and extraintestinal (EI) symptoms.
Exclusion: 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; 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; self-exclusion of wheat from the diet and refuse to reintroduce it for diagnostic purposes; pregnancy or breastfeeding.