Wheat sensitivity or IBS/functional dyspepsia in relatives of people with celiac disease
NCWS or IBS/FD in Relatives of CD Patients
This project will test whether adults related to celiac patients have higher rates of non-celiac wheat sensitivity or IBS/functional dyspepsia and whether symptoms change on a wheat-free diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Palermo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Palermo, PA and 1 other locations) |
| Trial ID | NCT07584473 on ClinicalTrials.gov |
What this trial studies
Researchers will recruit adult relatives of celiac disease patients who report IBS/FD-like or extraintestinal symptoms and screen them for non-celiac wheat sensitivity and IBS/FD. The work combines clinical evaluation with laboratory testing (including HLA DQ2/DQ8 status, intestinal permeability, and immunologic markers), gut microbiota analysis, and duodenal biopsy when indicated. Participants will be placed on a wheat-free diet and may undergo controlled wheat reintroduction for diagnostic purposes. Study outcomes include prevalence estimates, clinical and immunological profiles, changes in intestinal permeability and microbiota, and symptom response to dietary removal of wheat.
Who should consider this trial
Good fit: Adults (over 18) who are relatives (parents, grandparents, siblings, or children) of celiac disease patients, report IBS/FD-like or extraintestinal symptoms, and are willing to follow diagnostic wheat reintroduction if requested.
Not a fit: People with confirmed organic gastrointestinal diseases (including celiac disease or IgE-mediated wheat allergy), pregnant or breastfeeding individuals, those who already avoid wheat and refuse reintroduction, or people with recent substance abuse or recent steroid/NSAID use are unlikely to benefit.
Why it matters
Potential benefit: If successful, the project could identify relatives at higher risk for wheat-related symptoms and support targeted dietary or monitoring recommendations to reduce symptoms.
How similar studies have performed: Some prior work has shown immune or histologic gluten reactivity in relatives and identified an NCWS subgroup resembling celiac disease, but few studies have measured prevalence or tested wheat-free diets specifically in relatives.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Palermo, PA and 1 other locations
- Celiac Disease and Food Intolerance Clinic, Geriatrics Unit, "P. Giaccone" University Hospital, Palermo — Palermo, PA, Italy (Recruiting)
- Internal Medicine Unit, P.O. "V. Cervello," Ospedali Riuniti "Villa Sofia-Cervello," Palermo — Palermo, PA, Italy (Recruiting)
Study contacts
- Study coordinator: Pasquale Mansueto, MD
- Email: pasquale.mansueto@unipa.it
- Phone: +393477279879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.