Clinical trial NCT01478867: Detection of Immunotoxic Gluten Peptides in Feces
Official title: Phase 0 Monitoring of Gluten-free Diet Compliance in Celiac Patients by Assessment of Gliadin 33-mer Equivalent Epitopes in Feces
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Keywords: celiac disease
gluten-free diet
gluten peptides
feces
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Instituto Hispalense de Pediatría, Seville, Spain
First posted: 2011-11-23
Enrollment: 53
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Celiac patients, 1-12 years old

Brief 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.

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 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

Primary outcomes:
measure: Monitoring of gluten-free diet compliance in celiac patients
timeFrame: April-July 2011 (3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville
Study officials:
affiliation: University of Seville, Spain
name: Carolina Sousa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.