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Detection of Immunotoxic Gluten Peptides in Feces (CELIQK2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01478867
First Posted: November 23, 2011
Last Update Posted: November 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Instituto Hispalense de Pediatría, Seville, Spain
Information provided by (Responsible Party):
Carolina Sousa Martin, University of Seville
  Purpose
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.

Condition Intervention
Celiac Disease Other: Detection of gluten in feces

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Phase 0 Monitoring of Gluten-free Diet Compliance in Celiac Patients by Assessment of Gliadin 33-mer Equivalent Epitopes in Feces

Resource links provided by NLM:


Further study details as provided by Carolina Sousa Martin, University of Seville:

Primary Outcome Measures:
  • 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)


Biospecimen Retention:   Samples Without DNA
Fecal samples

Enrollment: 53
Study Start Date: April 2011
Study Completion Date: July 2011
Groups/Cohorts Assigned Interventions
Celiac patients Other: Detection of gluten in feces
Detection of Gluten in Feces
Other Names:
  • Gluten-free diet
  • Celiac patients

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Celiac patients, 1-12 years old
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478867


Locations
Spain
Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville
Seville, Spain, 41012
Sponsors and Collaborators
University of Seville
Instituto Hispalense de Pediatría, Seville, Spain
Investigators
Principal Investigator: Carolina Sousa, Professor University of Seville, Spain
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carolina Sousa Martin, Principal Investigator, University of Seville
ClinicalTrials.gov Identifier: NCT01478867     History of Changes
Other Study ID Numbers: CELIQK2
First Submitted: November 21, 2011
First Posted: November 23, 2011
Last Update Posted: November 24, 2011
Last Verified: November 2011

Keywords provided by Carolina Sousa Martin, University of Seville:
celiac disease
gluten-free diet
gluten peptides
feces

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases