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Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07584473

Study of Non-Celiac Wheat Sensitivity and IBSFunctional Dyspepsia in Adult Relatives of Celiac Disease Patients

Led by University of Palermo · Updated on 2026-05-13

600

Participants Needed

2

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the prevalence of non-celiac wheat sensitivity NCWS and irritable bowel syndromefunctional dyspepsia IBSFD not related to wheat ingestion among relatives of patients with celiac disease CD. This study aims to identify a subgroup of NCWS patients whose features are closer to CD than to IBSFD, particularly among CD patients relatives. The goal is to improve early diagnosis and understanding of these conditions, which may help reduce healthcare costs and improve quality of life for affected individuals. The study involves two main phases first, relatives of CD patients over 18 years old who report IBSFD-like and extraintestinal symptoms will complete questionnaires and undergo screenings including HLA typing and CD serology. Those suspected of having CD will receive a duodenal biopsy. In the second phase, identified patients will follow a strict six-week wheat-free diet WFD under dietician supervision. After the diet, symptom changes will be assessed to distinguish between self-reported NCWS and IBSFD not related to wheat intake. Participants will provide information through online questionnaires covering demographics, symptoms, and quality of life at multiple time points. Clinical assessments include serological tests, HLA typing, and biopsies when indicated. Researchers will monitor adherence to the wheat-free diet and measure symptom changes using validated rating scales over six weeks. The primary outcome is the identification of patients with self-reported NCWS or IBSFD not related to wheat intake using the Gastrointestinal Symptom Rating Scale GSRS from baseline to six weeks.

CONDITIONS

Brief Title

NCWS or IBS/FD in Relatives of CD Patients

Research Team

P

Pasquale Mansueto, MD

A

Aurelio Seidita, MD

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