Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04219813
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2019-12-30
Brief Title:
Urinary Gluten Immunogenic Peptides Detection in Non-celiac GlutenWheat Sensitivity
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
Urinary Gluten Detection in Patients With Non-celiac GlutenWheat Sensitivity
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Non-celiac glutenwheat sensitivity NCGSNCWS 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 glutenwheat in subjects in which celiac disease CD and wheat allergy diagnosis has been previously excluded NCGSNCWS symptoms generally occur after the ingestion of glutenwheat disappear within a few days of a gluten-free diet GFD and quickly reappear when glutenwheat 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 NCGSNCWS 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 symptomssigns appearing andor social activities eg meal in a restaurant The aims of the present study are 1 to test in patients with NCGSNCWS 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:
Non-celiac glutenwheat sensitivity NCGSNCWS 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 glutenwheat 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 NCGSNCWS symptoms generally occur after the ingestion of glutenwheat disappear within a few days of a gluten-free diet GFD and quickly reappear when glutenwheat 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 eg 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 NCGSNCWS 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 symptomssigns appearing andor social activities eg 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 NCGSNCWS The aims of the present study are 1 to test in patients with NCGSNCWS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None