Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-07 @ 6:48 AM
Study NCT ID:
NCT02612766
Status:
COMPLETED
Last Update Posted:
2017-08-03
First Post:
2015-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Oat Containing Gluten-free Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}, {'id': 'D015799', 'term': 'Gyrate Atrophy'}], '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'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2015-11-11', 'studyFirstSubmitQcDate': '2015-11-21', 'lastUpdatePostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in immunological activity of the disease measured by specific antibodies', 'timeFrame': 'After 6 weeks'}, {'measure': 'Change in patient symptoms assessed by validated questionnaire', 'timeFrame': 'After 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire', 'timeFrame': 'After 6 weeks'}]}, 'conditionsModule': {'keywords': ['celiac disease', 'oat', 'gluten free diet'], 'conditions': ['Celiac Disease']}, 'referencesModule': {'references': [{'pmid': '24201240', 'type': 'BACKGROUND', 'citation': 'Kaukinen K, Collin P, Huhtala H, Maki M. Long-term consumption of oats in adult celiac disease patients. Nutrients. 2013 Nov 6;5(11):4380-9. doi: 10.3390/nu5114380.'}, {'pmid': '24264227', 'type': 'BACKGROUND', 'citation': 'Gatti S, Caporelli N, Galeazzi T, Francavilla R, Barbato M, Roggero P, Malamisura B, Iacono G, Budelli A, Gesuita R, Catassi C, Lionetti E. Oats in the diet of children with celiac disease: preliminary results of a double-blind, randomized, placebo-controlled multicenter Italian study. Nutrients. 2013 Nov 20;5(11):4653-64. doi: 10.3390/nu5114653.'}, {'pmid': '23379438', 'type': 'BACKGROUND', 'citation': 'Cooper SE, Kennedy NP, Mohamed BM, Abuzakouk M, Dunne J, Byrne G, McDonald G, Davies A, Edwards C, Kelly J, Feighery CF. Immunological indicators of coeliac disease activity are not altered by long-term oats challenge. Clin Exp Immunol. 2013 Mar;171(3):313-8. doi: 10.1111/cei.12014.'}, {'pmid': '24916557', 'type': 'BACKGROUND', 'citation': 'Tapsas D, Falth-Magnusson K, Hogberg L, Hammersjo JA, Hollen E. Swedish children with celiac disease comply well with a gluten-free diet, and most include oats without reporting any adverse effects: a long-term follow-up study. Nutr Res. 2014 May;34(5):436-41. doi: 10.1016/j.nutres.2014.04.006. Epub 2014 Apr 18.'}, {'pmid': '24964993', 'type': 'BACKGROUND', 'citation': 'Sjoberg V, Hollen E, Pietz G, Magnusson KE, Falth-Magnusson K, Sundstrom M, Holmgren Peterson K, Sandstrom O, Hernell O, Hammarstrom S, Hogberg L, Hammarstrom ML. Noncontaminated dietary oats may hamper normalization of the intestinal immune status in childhood celiac disease. Clin Transl Gastroenterol. 2014 Jun 26;5(6):e58. doi: 10.1038/ctg.2014.9.'}, {'pmid': '24661128', 'type': 'BACKGROUND', 'citation': 'Tjellstrom B, Stenhammar L, Sundqvist T, Falth-Magnusson K, Hollen E, Magnusson KE, Norin E, Midtvedt T, Hogberg L. The effects of oats on the function of gut microflora in children with coeliac disease. Aliment Pharmacol Ther. 2014 May;39(10):1156-60. doi: 10.1111/apt.12707. Epub 2014 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and tolerability of oats in gluten free diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children over 4 years and adults with celiac disease (diagnosed according to current guidelines)\n* Subject is able to fully participate in all aspects of this clinical trial\n\nExclusion Criteria:\n\n* Known intolerance to oats\n* Serious underlying disease other than CD which in the opinion of the investigator may interfere with the subject's ability to fully participate in the study"}, 'identificationModule': {'nctId': 'NCT02612766', 'acronym': 'SafeOatDiet', 'briefTitle': 'Safety and Tolerability of Oat Containing Gluten-free Diet', 'organization': {'class': 'OTHER', 'fullName': 'Alfred Rusescu Institute for Mother and Child Care'}, 'officialTitle': 'SAFETY AND TOLERABILITY OF OAT CONTAINING GLUTEN-FREE DIET', 'orgStudyIdInfo': {'id': 'PCCA2-111/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm', 'description': 'This is a single-arm interventional study, in which each patient gets 50 grams/day of pure, uncontaminated oats', 'interventionNames': ['Dietary Supplement: Pure, uncontaminated oats']}], 'interventions': [{'name': 'Pure, uncontaminated oats', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucharest', 'country': 'Romania', 'facility': '"Alfred Rusescu" Institute for Mother and Child Care', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alfred Rusescu Institute for Mother and Child Care', 'class': 'OTHER'}, 'collaborators': [{'name': 'The National Research and Development Institute for Alimentary Bioresources, Bucharest', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}