NCWS or IBS/FD in Relatives of CD Patients
Recruiting now · Not applicable
Conditions studied: Non Celiac Wheat Sensitivity, IBS (Irritable Bowel Syndrome), Functional Dyspepsia, Celiac Disease
In brief
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).
Key facts
- Study ID
- NCT07584473
- Run by
- University of Palermo
- People needed
- 600
- Starts
- 2026-04-01
- Expected to finish
- 2028-04-30
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- CD patient's relatives
- >18 years old
- reporting IBS/FD-like and extraintestinal (EI) symptoms
You may not qualify if…
- 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.
Where it is running
- Celiac Disease and Food Intolerance Clinic, Geriatrics Unit, "P. Giaccone" University Hospital, Palermo — Palermo, PA, Italy (enrolling)
- Internal Medicine Unit, P.O. "V. Cervello," Ospedali Riuniti "Villa Sofia-Cervello," Palermo — Palermo, PA, Italy (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.