← Eichor
Study identifier: NCT04219813 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Non-celiac Gluten/Wheat Sensitivity  ·  Sponsor: University of Palermo

PhaseNA
Planned participants40
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Pasquale Mansueto, MD  ·  3477279879  ·  pasquale.mansueto@unipa.it

Always discuss trial participation with your own doctor first.

Locations (2)

Department of Internal Medicine, University Hospital of PalermoPalermo, Palermo, ItalyRecruiting
Internal Medicine Division of the "Cervello-Villa Sofia" HospitalPalermo, PA, ItalyRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT04219813