Testing for gluten sensitivity using urine samples
Urinary Gluten Detection in Patients With Non-celiac Gluten/Wheat Sensitivity
NA · University of Palermo · NCT04219813
This study is testing a new urine test to help people with gluten sensitivity see if they accidentally ate gluten while on a gluten-free diet.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Palermo (other) |
| Locations | 2 sites (Palermo, Palermo and 1 other locations) |
| Trial ID | NCT04219813 on ClinicalTrials.gov |
What this trial studies
This study focuses on non-celiac gluten/wheat sensitivity (NCGS/NCWS), a condition that causes various intestinal and extraintestinal symptoms after gluten ingestion in patients without celiac disease or wheat allergy. It utilizes a new urinary assay to detect gluten immunogenic peptides (GIP) in patients on a gluten-free diet, helping them identify accidental gluten consumption. The goal is to improve the management of NCGS/NCWS by providing patients with a tool to monitor their gluten intake and symptoms effectively.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with non-celiac gluten/wheat sensitivity who are currently following a gluten-free diet.
Not a fit: Patients with celiac disease or those suffering from IgE-mediated gluten/wheat allergy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for patients with gluten sensitivity by providing a reliable method to avoid gluten exposure.
How similar studies have performed: While this specific approach is novel, similar studies have shown promise in using biomarkers for dietary management in gluten sensitivity.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Palermo, Palermo and 1 other locations
- Department of Internal Medicine, University Hospital of Palermo — Palermo, Palermo, Italy (RECRUITING)
- Internal Medicine Division of the "Cervello-Villa Sofia" Hospital — Palermo, PA, Italy (RECRUITING)
Study contacts
- Principal investigator: Antonio Carroccio, PHD — University of Palermo
- Study coordinator: Pasquale Mansueto, MD
- Email: pasquale.mansueto@unipa.it
- Phone: 3477279879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-celiac Gluten/Wheat Sensitivity, Gluten Immunogenic Peptides, Celiac Disease