Actively Recruiting
NCWS or IBS/FD in Relatives of CD Patients
Led by University of Palermo · Updated on 2026-05-13
600
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
NCWS or IBS/FD in Relatives of CD Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be a relative of a celiac disease patient
- Be older than 18 years
- Have symptoms similar to irritable bowel syndrome or functional dyspepsia and extraintestinal symptoms
You will not qualify if you...
- Self-exclusion of wheat from the diet and refusal to reintroduce it for diagnostic purposes
- Abuse of drugs or alcohol (>30 g/day for men and >20 g/day for women)
- Treatment with steroids 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 digestive system diseases such as IgE-mediated wheat allergy, microscopic colitis, diverticulitis, segmental colitis with diverticulosis
- Neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, or impairments limiting physical activity
- Undergoing radiotherapy or chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Celiac Disease and Food Intolerance Clinic, Geriatrics Unit, "P. Giaccone" University Hospital, Palermo
Palermo, PA, Italy, 90127
Actively Recruiting
2
Internal Medicine Unit, P.O. "V. Cervello," Ospedali Riuniti "Villa Sofia-Cervello," Palermo
Palermo, PA, Italy, 90146
Actively Recruiting
Research Team
P
Pasquale Mansueto, MD
CONTACT
A
Aurelio Seidita, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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