A score that verifies adherence to a gluten-free diet: a cross-sectional, multicentre validation in real clinical life.
Federico Biagi, Paola Ilaria Bianchi, Alessandra Marchese...
https://pubmed.ncbi.nlm.nih.gov/22321199Actively Recruiting
Led by University of Palermo · Updated on 2026-05-13
600
Participants Needed
2
Research Sites
52 weeks
Total Duration
Researchers are investigating the prevalence of non-celiac wheat sensitivity (NCWS) and irritable bowel syndrome/functional dyspepsia (IBS/FD) 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 IBS/FD, 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 IBS/FD-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 IBS/FD 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 IBS/FD not related to wheat intake using the Gastrointestinal Symptom Rating Scale (GSRS) from baseline to six weeks.
CONDITIONS
NCWS or IBS/FD in Relatives of CD Patients
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (online questionnaire and clinical assessments)
Duration - Up to several weeks depending on clinical assessments
Participants complete clinical assessments including questionnaires, serological screening, and duodenal biopsy when necessary to identify symptoms related to celiac disease, non-celiac wheat sensitivity, or irritable bowel syndrome/functional dyspepsia.
1 to 2 visits depending on required tests
Duration - 6 weeks
Participants identified with IBS/FD-like and extraintestinal symptoms undergo a strict 6-week wheat-free diet with dietician consultation and complete follow-up questionnaires to evaluate symptom changes.
Weekly online questionnaires and 1 dietician consultation
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
P
Pasquale Mansueto, MD
A
Aurelio Seidita, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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