Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT01478867
Status:
COMPLETED
Last Update Posted:
2011-11-24
First Post:
2011-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Immunotoxic Gluten Peptides in Feces
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003672', 'term': 'Defecation'}, {'id': 'D055050', 'term': 'Diet, Gluten-Free'}], 'ancestors': [{'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Fecal samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-23', 'studyFirstSubmitDate': '2011-11-21', 'studyFirstSubmitQcDate': '2011-11-22', 'lastUpdatePostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monitoring of gluten-free diet compliance in celiac patients', 'timeFrame': 'April-July 2011 (3 months)', 'description': 'Usual gluten diet for celiac (home diet not modified for this trial)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['celiac disease', 'gluten-free diet', 'gluten peptides', 'feces'], 'conditions': ['Celiac Disease']}, 'referencesModule': {'references': [{'pmid': '18258632', 'type': 'BACKGROUND', '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.'}, {'pmid': '18509534', 'type': 'BACKGROUND', '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.'}, {'pmid': '12223360', 'type': 'BACKGROUND', '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.'}, {'pmid': '12351792', 'type': 'BACKGROUND', '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.'}, {'pmid': '22258271', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Celiac patients, 1-12 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Celiac patient\n* 1-12 years old\n* Written informed consent\n\nExclusion Criteria:\n\n* Known inflammatory bowel diseases\n* 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'}, 'identificationModule': {'nctId': 'NCT01478867', 'acronym': 'CELIQK2', 'briefTitle': 'Detection of Immunotoxic Gluten Peptides in Feces', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'Phase 0 Monitoring of Gluten-free Diet Compliance in Celiac Patients by Assessment of Gliadin 33-mer Equivalent Epitopes in Feces', 'orgStudyIdInfo': {'id': 'CELIQK2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Celiac patients', 'interventionNames': ['Other: Detection of gluten in feces']}], 'interventions': [{'name': 'Detection of gluten in feces', 'type': 'OTHER', 'otherNames': ['Gluten-free diet', 'Celiac patients'], 'description': 'Detection of Gluten in Feces', 'armGroupLabels': ['Celiac patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41012', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Department of Microbiology and Parasitology, Faculty of Pharmacy, University of Seville', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Carolina Sousa, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Seville, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Seville', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Hispalense de Pediatría, Seville, Spain', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Carolina Sousa Martin', 'investigatorAffiliation': 'University of Seville'}}}}