NCT02344758

Gluten-free Diet Monitoring in Urine

Non-invasive Gluten-free Diet Adherence Monitoring in Celiac Patients: Detection of Gluten Immunogenic Peptides in Urine

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DEVICE	Non-invasive lateral flow test for monitoring gluten intake
BEHAVIORAL	gluten-free diet (GFD)
BEHAVIORAL	gluten-containing diet

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-07-01
• Completion: 2013-12-01
• First posted: 2015-01-26
• Last updated: 2015-01-26

Locations

1 site across 1 country: Spain