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OpenTrials
Completed

NCT Number: NCT02344758

Gluten-free Diet Monitoring 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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Seville, 41012, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive lateral flow test for monitoring gluten intake

Device

gluten-free diet (GFD)

Behavioral

gluten-containing diet

Behavioral

Primary outcomes

  1. Usual gluten-containing diet for healthy individuals

    Time frame: 1 month

Secondary outcomes

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

    Time frame: 1 month

Other outcomes

  1. Gluten-challenge in healthy individuals on GFD with 10 to 50 mg gluten

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Collaborators

  • Hospitales Universitarios Virgen del Rocío
  • Instituto Hispalense de Pediatría

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 26, 2015
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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