Study Results
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Basic Information
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COMPLETED
EARLY_PHASE1
134 participants
INTERVENTIONAL
2013-04-30
2013-12-31
Brief Summary
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Detailed Description
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In this study, we have overcome these challenges and shown the feasibility of measuring gluten immunogenic peptides (GIP) in urine samples in healthy and celiac individuals by solid phase extraction and estimating the peptide concentrations with a reader of anti-GIP moAb immunochromatographic strips (IC-strips).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Study Groups
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Celiac adult
Patient \>16 years, initially diagnosed based on the detection of IgA anti-endomysial and anti-tissue transglutaminase antibodies in serum and confirmed by a small intestinal biopsy, on a GFD for \>2 years
Non-invasive lateral flow test for monitoring gluten intake
gluten-free diet (GFD)
Celiac child
Patient \<16 years, initially diagnosed based on the detection of IgA anti-endomysial and anti-tissue transglutaminase antibodies in serum and confirmed by a small intestinal biopsy, on a GFD for \>2 years
Non-invasive lateral flow test for monitoring gluten intake
gluten-free diet (GFD)
Healthy adult
Healthy individual \> 16 years. Exclusion criteria: the presence of family history of CD, digestive disease symptoms, known medical disease, use of prescription medications, and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study.
Non-invasive lateral flow test for monitoring gluten intake
gluten-containing diet
Healthy child
Healthy individual \< 16 years. Exclusion criteria: the presence of family history of CD, digestive disease symptoms, known medical disease, use of prescription medications, and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study.
Non-invasive lateral flow test for monitoring gluten intake
gluten-containing diet
Interventions
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Non-invasive lateral flow test for monitoring gluten intake
gluten-free diet (GFD)
gluten-containing diet
Eligibility Criteria
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Inclusion Criteria
* written informed consent
Exclusion Criteria
* digestive disease symptoms
* known medical disease
* use of prescription medications and use of antibiotics and probiotics in the previous 2 months to the inclusion in the study
* 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
3 Years
ALL
No
Sponsors
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Instituto Hispalense de Pediatría
UNKNOWN
Hospitales Universitarios Virgen del Rocío
OTHER
University of Seville
OTHER
Responsible Party
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Carolina Sousa Martin
Professor
Principal Investigators
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Mª de Lourdes Moreno Amador, Dr
Role: STUDY_CHAIR
Department of Microbiology and Parasitology, University of Sevilla, Spain
Ángel Cebolla Ramírez, Dr
Role: STUDY_CHAIR
Biomedal S.L.
Ángeles Pizarro Moreno, Dr
Role: STUDY_CHAIR
Unidad Clínica de Aparato Digestivo, Hospital Universitario Virgen del Rocío, Sevilla, Spain
Alba Muñoz Suano, Dr
Role: STUDY_CHAIR
Biomedal, S.L., Sevilla, Spain
Isabel Comino Montilla, Dr
Role: STUDY_CHAIR
Department of Microbiology and Parasitology, University of Sevilla, Spain
Alfonso Rodríguez Herrera, Dr
Role: STUDY_CHAIR
Unidad de Gastroenterología y Nutrición, Instituto Hispalense de Pediatría. Sevilla, Spain
Francisco León, Dr
Role: STUDY_CHAIR
Celimmune, Bethesda, MD, USA
Carolina Carrillo Carrión
Role: STUDY_CHAIR
Biomedal, S.L., Sevilla, Spain
Carolina Sousa Martín, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Microbiology and Parasitology, University of Sevilla, Spain
Locations
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Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville
Seville, Seville, Spain
Countries
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References
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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.
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.
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.
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.
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.
Comino I, Real A, Moreno Mde L, Montes R, Cebolla A, Sousa C. Immunological determination of gliadin 33-mer equivalent peptides in beers as a specific and practical analytical method to assess safety for celiac patients. J Sci Food Agric. 2013 Mar 15;93(4):933-43. doi: 10.1002/jsfa.5830. Epub 2012 Aug 6.
Real A, Comino I, Moreno Mde L, Lopez-Casado MA, Lorite P, Torres MI, Cebolla A, Sousa C. Identification and in vitro reactivity of celiac immunoactive peptides in an apparent gluten-free beer. PLoS One. 2014 Jun 25;9(6):e100917. doi: 10.1371/journal.pone.0100917. eCollection 2014.
Moreno ML, Cebolla A, Munoz-Suano A, Carrillo-Carrion C, Comino I, Pizarro A, Leon F, Rodriguez-Herrera A, Sousa C. Detection of gluten immunogenic peptides in the urine of patients with coeliac disease reveals transgressions in the gluten-free diet and incomplete mucosal healing. Gut. 2017 Feb;66(2):250-257. doi: 10.1136/gutjnl-2015-310148. Epub 2015 Nov 25.
Other Identifiers
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CELIFLUID1
Identifier Type: -
Identifier Source: org_study_id
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