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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• patients suffering from NCGS/NCWS on Gluten-Free Diet (GFD).

Locations
Other Locations
Italy
Department of Internal Medicine, University Hospital of Palermo
RECRUITING
Palermo
Internal Medicine Division of the Cervello-Villa Sofia Hospital
RECRUITING
Palermo
Contact Information
Primary
Pasquale Mansueto, MD
pasquale.mansueto@unipa.it
3477279879
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 40
Treatments
Other: Patients affected with Non-celiac Gluten/Wheat Sensitivity
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.
Sponsors
Leads: University of Palermo

This content was sourced from clinicaltrials.gov