Detection of Immunotoxic Gluten Peptides in Feces

NCT01478867 | Completed

• 1 other identifier: CELIQK2
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

celiac disease; gluten-free diet; gluten peptides; feces

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Celiac patients

Other: Detection of gluten in feces

Interventions

Detection of gluten in feces OTHER

Detection of Gluten in Feces

Also known as: Gluten-free diet, Celiac patients

Celiac patients

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Celiac patients, 1-12 years old

You may qualify if:

• Celiac patient
• years old
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Seville: lead
• Instituto Hispalense de Pediatría, Seville, Spain: collaborator

Study Sites (1)

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

Seville, Seville, 41012, Spain

Location

Related Publications (5)

• 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.

  PMID: 18258632 BACKGROUND

• 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.

  PMID: 18509534 BACKGROUND

• 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.

  PMID: 12223360 BACKGROUND

• 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.

  PMID: 12351792 BACKGROUND

• 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.

  PMID: 22258271 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal samples

MeSH Terms

Conditions

Celiac Disease

Interventions

Defecation; Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Carolina Sousa, Professor

  University of Seville, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: April 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 24, 2011

Record last verified: 2011-11

Locations

ES (1)