Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients suffering from NCGS/NCWS on Gluten-Free Diet (GFD).
You will not qualify if you...
- Patients diagnosed with celiac disease.
- Patients diagnosed with IgE-mediated gluten/wheat allergy.
AI-Screening
AI-Powered 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
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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