Detection of Immunotoxic Gluten Peptides in Feces

Celiac Disease Clinical Trial

— CELIQK2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478867
• Other study ID #: CELIQK2
• Status: Completed
• Phase: N/A
• First received: November 21, 2011
• Last updated: November 23, 2011
• Start date: April 2011
• Est. completion date: July 2011

Study information

• Verified date: November 2011
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Other:
• Detection of gluten in feces
Detection of Gluten in Feces

Locations

Country	Name	City	State
Spain	Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville	Seville

Sponsors (2)

Lead Sponsor	Collaborator
University of Seville	Instituto Hispalense de Pediatría, Seville, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

Morón B, Bethune MT, Comino I, Manyani H, Ferragud M, López 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. — View Citation

Morón B, Cebolla A, Manyani H, Alvarez-Maqueda M, Megías M, Thomas Mdel C, López 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. — View Citation

Shan L, Molberg Ø, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring of gluten-free diet compliance in celiac patients	Usual gluten diet for celiac (home diet not modified for this trial)	April-July 2011 (3 months)	No