An interventional study of Urinary test in Non-celiac Gluten/Wheat Sensitivity, sponsored by University of Palermo. Recruiting at 2 sites in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by University of Palermo · Not applicable, Interventional, and Other
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.
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. Recent data suggest that NCGS affect up to 3-6% of the general population, a higher prevalence than that reported for CD. 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. GDF is very difficult and onerous from a social (presence of gluten in many industrial food products and "contamination", both domestic and extra-domestic), psychological (e.g. for adolescents, exclusion from the "peer group", with difficulty in accepting the diagnosis) and economic point of view. 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 other one involves collecting a stool sample and allows to identify the gluten taken in the previous week, but it requires a laboratory, specifically equipped. To date, there are no observational studies that indicate the performance of the test in patients with NCGS/NCWS. 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.
352 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 214 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →University of Palermo is the lead sponsor of 145 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
The researchers will deliver to each patient 10 kits for the analysis of the GIP and they will ask them to use them two times per week, for 5 weeks. Furthermore, the patients will test urine GIP in the event of symptoms/signs that they attribute to the accidental intake of gluten, within the same 5 weeks. Both gastrointestinal and extra-intestinal symptoms which the patients will attribute to the accidental intake of gluten, will be considered.
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.
Also known as: Detection of the presence of gluten immunogenic peptides (GIP) in the urine
Adherence to GFD of NCGS/NCWS patients
The researchers will evaluate the adherence to Gluten-Free Diet (GFD) of NCGS/NCWS patients on GFD by the absence/presence of gluten immunogenic peptides (GIP) in their urine samples.
Time frame: 24 months
Gastrointestinal and extraintestinal symptoms/signs reappearance
The researchers will evaluate the correlation between gastrointestinal (evaluated by the Gastrointestinal Symptom Rating Scale, GSRS) and/or extraintestinal (evaluated by an ad hoc Scale) symptoms/signs reappearance and the presence of gluten immunogenic peptides (GIP) in the urine of NCGS/NCWS patients on Gluten-Free Diet (GFD), by possible accidental intake.
Time frame: 24 months
Plan to share: No
Ran from Jan 2021 to primary completion in Dec 2025, 59 months.
Of 82 non-industry interventional studies with no phase under Celiac Disease, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's 59 months is above that.
Counting every sponsor, half of 87 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
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