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Detection of Immunotoxic Gluten Peptides in Feces (CELIQK2)

This study has been completed.
Sponsor:
Collaborator:
Instituto Hispalense de Pediatría, Seville, Spain
Information provided by (Responsible Party):
Carolina Sousa Martin, University of Seville
ClinicalTrials.gov Identifier:
NCT01478867
First received: November 21, 2011
Last updated: November 23, 2011
Last verified: November 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by University of Seville:

Primary Outcome Measures:
  • Monitoring of gluten-free diet compliance in celiac patients [ Time Frame: April-July 2011 (3 months) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional 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
Study First Received: November 21, 2011
Last Updated: November 23, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 21, 2013