Gluten-free Diet Monitoring in Urine

Early Phase 1CompletedNCT02344758

University of Seville134 enrolled

Overview

The purpose of this study is to develope a novel method to determine gluten intake and to check gluten-free diet adherence in celiac patients by detection of gluten immunogenic peptides in urine.

To date, the mainstay of the management of CD is a strict life-long adherence to gluten-free diet (GFD). Follow-up monitoring of the improvement of patients on GFD is essential to assess symptomatic recovery and to monitor complications, as well as to assist patients with dietary compliance. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available. In this study, we have overcome these challenges and shown the feasibility of measuring gluten immunogenic peptides (GIP) in urine samples in healthy and celiac individuals by solid phase extraction and estimating the peptide concentrations with a reader of anti-GIP moAb immunochromatographic strips (IC-strips).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Enrollment

134

Conditions

Celiac Disease

Interventions

Non-invasive lateral flow test for monitoring gluten intakeDEVICE

gluten-free diet (GFD)BEHAVIORAL

gluten-containing dietBEHAVIORAL

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Celiac patient: childs (\< 16 years) and adults (\> 16 years) * written informed consent Exclusion Criteria: * presence of family history of CD * digestive disease symptoms * known medical disease * use of prescription medications and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study * participation in any other studies involving investigational concomitantly or within two weeks prior to entry into the study and during the course of the study

Locations (1)

Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville

Seville, Seville, Spain

Outcomes

Primary Outcomes

Usual gluten-containing diet for healthy individuals

Time frame: 1 month

Secondary Outcomes

Usual gluten-free diet for celiac patients (home diet not modified for this trial)

Time frame: 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.