Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction.
Douglas A Drossman, William L Hasler
https://pubmed.ncbi.nlm.nih.gov/27147121/Actively 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 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
NCWS or IBS/FD in Relatives of CD Patients
P
Pasquale Mansueto, MD
A
Aurelio Seidita, MD
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University of Palermo
Lead Sponsor
You may qualify if you...
You will not qualify if you...
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Douglas A Drossman, William L Hasler
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https://pubmed.ncbi.nlm.nih.gov/32658621/University of Palermo
Lead Sponsor