Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07584473

NCWS or IBS/FD in Relatives of Celiac Disease Patients A Study Evaluating Symptom Prevalence and Wheat-Free Diet Effects

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

600

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

NCWS or IBS/FD in Relatives of CD Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be a relative (parent, grandparent, sibling, or child) of a patient with celiac disease
  • Be 18 years old or older
  • Report symptoms similar to irritable bowel syndrome or functional dyspepsia, including extraintestinal symptoms
Not Eligible

You will not qualify if you...

  • Have already excluded wheat from your diet and refuse to reintroduce it for diagnostic purposes
  • Abuse drugs and/or alcohol (more than 30 g/day for men, more than 20 g/day for women)
  • Have used steroids or non-steroidal anti-inflammatory drugs in the two weeks before biopsy
  • Are pregnant or breastfeeding
  • Have chronic inflammatory bowel disease or other organic digestive conditions such as wheat allergy, microscopic colitis, diverticulitis, or segmental colitis
  • Have neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, or physical impairments limiting activity
  • Are undergoing radiotherapy or chemotherapy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (online questionnaire and clinical assessments)

Diagnostic Evaluation

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

Treatment

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

Trial Site Locations

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

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Research Team

P

Pasquale Mansueto, MD

A

Aurelio Seidita, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

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/22321199

Divergence of gut permeability and mucosal immune gene expression in two gluten-associated conditions: celiac disease and gluten sensitivity.

Anna Sapone, Karen M Lammers, Vincenzo Casolaro...

https://pubmed.ncbi.nlm.nih.gov/21392369

TNF-α, IL-17, and IL-22 production in the rectal mucosa of nonceliac wheat sensitivity patients: role of adaptive immunity.

Pasquale Mansueto, Diana Di Liberto, Francesca Fayer...

https://pubmed.ncbi.nlm.nih.gov/32658621

Spectrum of gluten-sensitive enteropathy in first-degree relatives of patients with coeliac disease: clinical relevance of lymphocytic enteritis.

M Esteve, M Rosinach, F Fernández-Bañares...

https://pubmed.ncbi.nlm.nih.gov/16709658

Predominance of Type 1 Innate Lymphoid Cells in the Rectal Mucosa of Patients With Non-Celiac Wheat Sensitivity: Reversal After a Wheat-Free Diet.

Diana Di Liberto, Pasquale Mansueto, Alberto D'Alcamo...

https://pubmed.ncbi.nlm.nih.gov/27388423