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Completed

NCT Number: NCT01478867

Detection of Immunotoxic Gluten Peptides in Feces

The purpose of this study is to monitor of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces.

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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

1 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Seville, 41012, Spain

About this study

Certain immunotoxic peptides from gluten are resistant to gastrointestinal digestion and can interact with celiac patient factors to trigger immunological response. Gluten-free diet (GFD) is the only effective treatment for celiac disease (CD) and its compliance should be monitored to avoid accumulative damage. However, practical methods to monitor diet compliance and to detect the origin of an outbreak of celiac clinical symptoms are not available.

This study assesses the capacity to determine the gluten ingestion, and to monitor the GFD compliance in celiac patients by detection of gluten and gliadin 33-mer equivalent peptidic epitopes in human feces.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Celiac patient
  • 1-12 years old
  • Written informed consent

Exclusion criteria

  • Known inflammatory bowel diseases
  • 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

Detection of gluten in feces

Other

Detection of Gluten in Feces

Other names: Gluten-free diet, Celiac patients

Primary outcomes

  1. Monitoring of gluten-free diet compliance in celiac patients

    Time frame: April-July 2011 (3 months)

    Usual gluten diet for celiac (home diet not modified for this trial)

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Collaborators

  • Instituto Hispalense de Pediatría, Seville, Spain

Registry information

Official study title

Phase 0 Monitoring of Gluten-free Diet Compliance in Celiac Patients by Assessment of Gliadin 33-mer Equivalent Epitopes in Feces

Acronym: CELIQK2

Important dates

Study start
2011
Study completion
2011
First posted
Nov 23, 2011
Registry last updated
Nov 24, 2011

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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