Urinary Gluten Immunogenic Peptides Detection in Non-celiac Gluten/Wheat Sensitivity
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Non-celiac Gluten/Wheat Sensitivity
In brief
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.
Key facts
- Study ID
- NCT04219813
- Run by
- University of Palermo
- People needed
- 40
- Starts
- 2021-01-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-29
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- patients suffering from NCGS/NCWS on Gluten-Free Diet (GFD).
You may not qualify if…
- celiac patients or those suffering from IgE-mediated gluten/wheat allergy.
Where it is running
- Department of Internal Medicine, University Hospital of Palermo — Palermo, Palermo, Italy (enrolling)
- Internal Medicine Division of the "Cervello-Villa Sofia" Hospital — Palermo, PA, Italy (enrolling)
Full record on ClinicalTrials.gov
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