NCT07584473 NCWS or IBS/FD in Relatives of CD Patients
| NCT ID | NCT07584473 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Palermo |
| Condition | Non Celiac Wheat Sensitivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2026-04-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Antonio Carroccio, MD
STUDY DIRECTOR
University of Palermo
Frequently Asked Questions
Who can join the NCT07584473 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Celiac Wheat Sensitivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07584473 currently recruiting?
Yes, NCT07584473 is actively recruiting participants. Contact the research team at pasquale.mansueto@unipa.it for enrollment information.
Where is the NCT07584473 trial being conducted?
This trial is being conducted at Palermo, Italy, Palermo, Italy.
Who is sponsoring the NCT07584473 clinical trial?
NCT07584473 is sponsored by University of Palermo. The principal investigator is Antonio Carroccio, MD at University of Palermo. The trial plans to enroll 600 participants.