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Clinical Trials/NCT02344758
NCT02344758CompletedEarly Phase 1

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

University of Seville2 sites in 1 country134 target enrollmentStarted: April 2013Last updated:
Conditions

Trial Snapshot

Phase
Early Phase 1
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carolina Sousa Martin

Professor

University of Seville

Study Sites (2)

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