Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT04219813

Urinary Gluten Immunogenic Peptides Detection in Non-celiac Gluten/Wheat Sensitivity

Led by University of Palermo · Updated on 2026-04-29

40

Participants Needed

2

Research Sites

312 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Non-celiac gluten/wheat sensitivity (NCGS/NCWS) is a syndrome characterized by both intestinal (irritable bowel syndrome \[IBS\]-like presentation) and extraintestinal symptoms (headache, migraine, "foggy mind", depression, anxiety, fibromyalgia, joint and muscle pain, leg or arm numbness, eczema or skin rash), which occur after the ingestion of gluten/wheat in subjects in which celiac disease (CD) and wheat allergy diagnosis has been previously excluded. NCGS/NCWS symptoms generally occur after the ingestion of gluten/wheat, disappear within a few days of a gluten-free diet (GFD) and quickly reappear when gluten/wheat is reintroduced. A new assay, recently available on the Italian market, allows to ascertain the presence of immunogenic peptides of gluten (Gluten Immunogenic Peptides, GIP) in the urine and stool. The test might allow to ascertain if the NCGS/NCWS patients, on GFD, eat, even accidentally, gluten. Of the 2 available assays, the urinary one allows the patient himself to test the presence of GIP in relation to symptoms/signs appearing and/or social activities (e.g. meal in a restaurant). The aims of the present study are: 1) to test, in patients with NCGS/NCWS on GFD, the adherence to the elimination diet; 2) to evaluate the correlation between the symptoms' reappearance and the presence of GIP in the urine.

CONDITIONS

Official Title

Urinary Gluten Immunogenic Peptides Detection in Non-celiac Gluten/Wheat Sensitivity

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients suffering from NCGS/NCWS on Gluten-Free Diet (GFD).
Not Eligible

You will not qualify if you...

  • Patients diagnosed with celiac disease.
  • Patients diagnosed with IgE-mediated gluten/wheat allergy.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Department of Internal Medicine, University Hospital of Palermo

Palermo, Palermo, Italy, 90127

Actively Recruiting

2

Internal Medicine Division of the "Cervello-Villa Sofia" Hospital

Palermo, PA, Italy, 90129

Actively Recruiting

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Research Team

P

Pasquale Mansueto, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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