Clinical trial Recruiting at 2 sites Interventional Ages 18 to 75

Testing for gluten sensitivity using urine samples

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

Run by University of Palermo · NCT04219813 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment40 (estimated)
SponsorUniversity of Palermo
Academic / other
Locations2 sites (Palermo, Palermo and 1 other locations)
StatusRecruiting
StartedJanuary 1, 2021
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedApril 29, 2026
Trial IDNCT04219813 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals diagnosed with non-celiac gluten/wheat sensitivity who are currently following a gluten-free diet.

Probably not a fit

Patients with celiac disease or those suffering from IgE-mediated gluten/wheat allergy will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While this specific approach is novel, similar studies have shown promise in using biomarkers for dietary management in gluten sensitivity.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.