Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT01116505
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
2010-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Screen-detected Celiac Disease
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': 'D055050', 'term': 'Diet, Gluten-Free'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-24', 'studyFirstSubmitDate': '2010-05-03', 'studyFirstSubmitQcDate': '2010-05-04', 'lastUpdatePostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Small-bowel mucosal morphology and inflammation', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Endomysial antibodies', 'timeFrame': 'one year'}, {'measure': 'Tissue transglutaminase antibodies', 'timeFrame': 'one year'}, {'measure': 'Antibodies to deamidated gliadin', 'timeFrame': 'one year'}, {'measure': 'Intestinal tissue transglutaminase-specific IgA deposits', 'timeFrame': 'one year'}, {'measure': 'Bone mineral density', 'timeFrame': 'one year'}, {'measure': 'Body composition', 'timeFrame': 'one year'}, {'measure': 'Health-related quality of life', 'timeFrame': 'one year'}, {'measure': 'Laboratory parameters', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Celiac disease', 'Endomysial antibodies', 'Gluten-free diet', 'Screen-detected', 'Asymptomatic', 'Bone mineral density'], 'conditions': ['Celiac Disease']}, 'referencesModule': {'references': [{'pmid': '24837306', 'type': 'DERIVED', 'citation': 'Kurppa K, Paavola A, Collin P, Sievanen H, Laurila K, Huhtala H, Saavalainen P, Maki M, Kaukinen K. Benefits of a gluten-free diet for asymptomatic patients with serologic markers of celiac disease. Gastroenterology. 2014 Sep;147(3):610-617.e1. doi: 10.1053/j.gastro.2014.05.003. Epub 2014 May 13.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.', 'detailedDescription': 'Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive endomysial antibodies\n* Adults\n\nExclusion Criteria:\n\n* Previous celiac disease diagnosis\n* Significant clinical symptoms\n* Suspicion of any serious celiac disease-associated complication\n* Suspected or diagnosed severe illness other than celiac disease\n* Consuming oral corticosteroids or immune suppressants\n* Marked laboratory abnormalities'}, 'identificationModule': {'nctId': 'NCT01116505', 'briefTitle': 'Treatment of Screen-detected Celiac Disease', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Treatment of Screen-detected Celiac Disease in Adults', 'orgStudyIdInfo': {'id': 'R07122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'gluten-containing diet'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active comparator, gluten-free diet', 'interventionNames': ['Dietary Supplement: Gluten-free diet']}], 'interventions': [{'name': 'Gluten-free diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'gluten-containing cereals removed from diet', 'armGroupLabels': ['Active comparator, gluten-free diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Tampere', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'Pediatric Research Centre, Tampere University Hospital and University of Tampere', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Katri Kaukinen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tampere, Tampere University hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D, Ph.D, Pediatrician', 'investigatorFullName': 'Kalle Kurppa', 'investigatorAffiliation': 'Tampere University Hospital'}}}}