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Detection of Immunotoxic Gluten Peptides in Feces

NCT ID: NCT01478867

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Celiac Disease

Keywords

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celiac disease gluten-free diet gluten peptides feces

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Celiac patients

Detection of gluten in feces

Intervention Type OTHER

Detection of Gluten in Feces

Interventions

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Detection of gluten in feces

Detection of Gluten in Feces

Intervention Type OTHER

Other Intervention Names

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Gluten-free diet Celiac patients

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Hispalense de Pediatría, Seville, Spain

UNKNOWN

Sponsor Role collaborator

University of Seville

OTHER

Sponsor Role lead

Responsible Party

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Carolina Sousa Martin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolina Sousa, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Seville, Spain

Locations

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

Seville, Seville, Spain

Site Status

Countries

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Spain

References

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Moron B, Cebolla A, Manyani H, Alvarez-Maqueda M, Megias M, Thomas Mdel C, Lopez MC, Sousa C. Sensitive detection of cereal fractions that are toxic to celiac disease patients by using monoclonal antibodies to a main immunogenic wheat peptide. Am J Clin Nutr. 2008 Feb;87(2):405-14. doi: 10.1093/ajcn/87.2.405.

Reference Type BACKGROUND
PMID: 18258632 (View on PubMed)

Moron B, Bethune MT, Comino I, Manyani H, Ferragud M, Lopez MC, Cebolla A, Khosla C, Sousa C. Toward the assessment of food toxicity for celiac patients: characterization of monoclonal antibodies to a main immunogenic gluten peptide. PLoS One. 2008 May 28;3(5):e2294. doi: 10.1371/journal.pone.0002294.

Reference Type BACKGROUND
PMID: 18509534 (View on PubMed)

Hausch F, Shan L, Santiago NA, Gray GM, Khosla C. Intestinal digestive resistance of immunodominant gliadin peptides. Am J Physiol Gastrointest Liver Physiol. 2002 Oct;283(4):G996-G1003. doi: 10.1152/ajpgi.00136.2002.

Reference Type BACKGROUND
PMID: 12223360 (View on PubMed)

Shan L, Molberg O, Parrot I, Hausch F, Filiz F, Gray GM, Sollid LM, Khosla C. Structural basis for gluten intolerance in celiac sprue. Science. 2002 Sep 27;297(5590):2275-9. doi: 10.1126/science.1074129.

Reference Type BACKGROUND
PMID: 12351792 (View on PubMed)

Comino I, Real A, Vivas S, Siglez MA, Caminero A, Nistal E, Casqueiro J, Rodriguez-Herrera A, Cebolla A, Sousa C. Monitoring of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces. Am J Clin Nutr. 2012 Mar;95(3):670-7. doi: 10.3945/ajcn.111.026708. Epub 2012 Jan 18.

Reference Type DERIVED
PMID: 22258271 (View on PubMed)

Other Identifiers

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CELIQK2

Identifier Type: -

Identifier Source: org_study_id