Gluten-free Diet Monitoring in Urine

January 22, 2015 updated by: Carolina Sousa Martin, University of Seville

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

134

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41012
        • Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Celiac adult
Patient >16 years, initially diagnosed based on the detection of IgA anti-endomysial and anti-tissue transglutaminase antibodies in serum and confirmed by a small intestinal biopsy, on a GFD for >2 years
Device: Non-invasive lateral flow test for monitoring gluten intake
Behavioral: gluten-free diet (GFD)
Experimental: Celiac child
Patient <16 years, initially diagnosed based on the detection of IgA anti-endomysial and anti-tissue transglutaminase antibodies in serum and confirmed by a small intestinal biopsy, on a GFD for >2 years
Device: Non-invasive lateral flow test for monitoring gluten intake
Behavioral: gluten-free diet (GFD)
Active Comparator: Healthy adult
Healthy individual > 16 years. Exclusion criteria: the 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.
Device: Non-invasive lateral flow test for monitoring gluten intake
Behavioral: gluten-containing diet
Active Comparator: Healthy child
Healthy individual < 16 years. Exclusion criteria: the 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.
Device: Non-invasive lateral flow test for monitoring gluten intake
Behavioral: gluten-containing diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Usual gluten-containing diet for healthy individuals
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Usual gluten-free diet for celiac patients (home diet not modified for this trial)
Time Frame: 1 month
1 month

Other Outcome Measures

Outcome Measure
Time Frame
Gluten-challenge in healthy individuals on GFD with 10 to 50 mg gluten
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Collaborators

Hospitales Universitarios Virgen del Rocío
Instituto Hispalense de Pediatría

Investigators

  • Study Chair: Mª de Lourdes Moreno Amador, Dr, Department of Microbiology and Parasitology, University of Sevilla, Spain
  • Study Chair: Ángel Cebolla Ramírez, Dr, Biomedal S.L.
  • Study Chair: Ángeles Pizarro Moreno, Dr, Unidad Clínica de Aparato Digestivo, Hospital Universitario Virgen del Rocío, Sevilla, Spain
  • Study Chair: Alba Muñoz Suano, Dr, Biomedal, S.L., Sevilla, Spain
  • Study Chair: Isabel Comino Montilla, Dr, Department of Microbiology and Parasitology, University of Sevilla, Spain
  • Study Chair: Alfonso Rodríguez Herrera, Dr, Unidad de Gastroenterología y Nutrición, Instituto Hispalense de Pediatría. Sevilla, Spain
  • Study Chair: Francisco León, Dr, Celimmune, Bethesda, MD, USA
  • Study Chair: Carolina Carrillo Carrión, Biomedal, S.L., Sevilla, Spain
  • Principal Investigator: Carolina Sousa Martín, Professor, Department of Microbiology and Parasitology, University of Sevilla, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELIFLUID1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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