Non-invasive Gluten-free Diet Adherence Monitoring in Celiac Patients: Detection of Gluten Immunogenic Peptides in Urine
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- University of Seville
- Enrollment
- 134
- Locations
- 2
- Primary Endpoint
- Usual gluten-containing diet for healthy individuals
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
Eligibility Criteria
- Ages
- 3 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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)(1 month)
Investigators
Carolina Sousa Martin
Professor
University of Seville