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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Urinary Gluten Detection in Patients With Non-celiac Gluten/Wheat Sensitivity

Conditions
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Non-celiac Gluten/Wheat Sensitivity

Intervention / Treatment
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* Other: Urinary test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The researchers will evaluate the urine samples of patients affected with NCGS/NCWS, diagnosed by double-blind placebo-controlled wheat challenge, on GFD. The patients will be recruited among those diagnosed in two centers: Ambulatorio di Celiachia ed Intolleranze Alimentari (Prof. Pasquale Mansueto) of the Geriatric Division (Director Prof. Mario Barbagallo) of the Azienda Ospedaliera-Universitaria Paolo Giaccone', and the Internal Medicine Unit (Director Prof. Antonio Carroccio) of the Cervello-Villa Sofia Hospital, both in Palermo, Italy. The researchers will deliver to each patient 10 kits for the analysis of the GIP and we 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients affected with Non-celiac Gluten/Wheat Sensitivity<br>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<br>* 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.<br>* Other names: Detection of the presence of gluten immunogenic peptides (GIP) in the urine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-celiac Gluten/Wheat Sensitivity, Gluten Immunogenic Peptides, Celiac Disease