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RECRUITINGINTERVENTIONAL

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

Urinary Gluten Detection in Patients with Non-celiac Gluten/Wheat Sensitivity

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - patients suffering from NCGS/NCWS on Gluten-Free Diet (GFD). Who Should NOT Join This Trial: - celiac patients or those suffering from IgE-mediated gluten/wheat allergy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * patients suffering from NCGS/NCWS on Gluten-Free Diet (GFD). Exclusion Criteria: * celiac patients or those suffering from IgE-mediated gluten/wheat allergy.

Treatments Being Tested

OTHER

Urinary test

Detection of the presence of gluten immunogenic peptides (GIP) in the urine of NCGS/NCWS patients, evaluated two times per week, for 5 weeks, and in the event of symptoms/signs that the patients attribute to the accidental intake of gluten, within the same 5 weeks.

Locations (2)

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