Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT03492333
Status:
COMPLETED
Last Update Posted:
2018-04-10
First Post:
2018-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gluten Free Diet in IBS Patients Stratified According to Their Antigliadin Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intervention GFD in IBS and HV(controls)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement on gastrointestinal symptoms', 'timeFrame': '4 weeks', 'description': 'Decrease \\>2 points IBS Birmingham score'}], 'secondaryOutcomes': [{'measure': 'Normalization of gastrointestinal transit', 'timeFrame': '4 weeks', 'description': '(SHAPE 25-50 radiopaque markers)'}, {'measure': 'Improvement anxiety and/or depression', 'timeFrame': '4 weeks', 'description': 'Decrease \\>2 points Hospital anxiety and depression (HAD) score'}, {'measure': 'Improvement somatization', 'timeFrame': '4 weeks', 'description': 'Decrease somatization scores (PHQ15)'}, {'measure': 'Improvement quality of life and well-being', 'timeFrame': '4 weeks', 'description': 'Decrease in the psychological general well-being (PGWB) score'}, {'measure': 'Changes in gut microbiota', 'timeFrame': '4 weeks', 'description': 'changes in microbial composition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antigliadin, gluten free diet, transit'], 'conditions': ['IBS - Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '32827724', 'type': 'DERIVED', 'citation': 'Pinto-Sanchez MI, Nardelli A, Borojevic R, De Palma G, Calo NC, McCarville J, Caminero A, Basra D, Mordhorst A, Ignatova E, Hansen S, Uhde M, Norman GL, Murray JA, Smecuol E, Armstrong D, Bai JC, Schuppan D, Collins SM, Alaedini A, Moayyedi P, Verdu EF, Bercik P. Gluten-Free Diet Reduces Symptoms, Particularly Diarrhea, in Patients With Irritable Bowel Syndrome and Antigliadin IgG. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2343-2352.e8. doi: 10.1016/j.cgh.2020.08.040. Epub 2020 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'Gluten-free diet has been shown to improve gut symptoms in patients with celiac disease and also in adult patients with diagnosis of Irritable Bowel Syndrome (Rome III criteria).\n\nAntibodies to native gliadin (AGA) have been suggested as a potential diagnostic marker of response to GFD. However, this has not been tested in a prospective study in IBS patients. Identification of predictors of a symptomatic response to GFD within the IBS population would improve the clinical management of these patients.\n\nThe purpose of this study is to evaluate the effect of gluten-free diet on gastrointestinal symptoms and gut motility in patients with Irritable Bowel Syndrome stratified according to their antigliadin antibodies status.\n\nAdditional purposes include investigating effects gluten free diet may have on other parameters:\n\n* Improvement of mood\n* Quality of life and general well-being\n* Changes in gut microbiota'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* IBS diagnosis (Rome III)\n* Willingness to participate\n\nExclusion Criteria:\n\n* history of any organic disease including celiac disease\n* Immune deficiency\n* Major abdominal surgery\n* Use of immunosuppressants, glucocorticosteroids or opioids\n* Use of antibiotics in the last 3 months'}, 'identificationModule': {'nctId': 'NCT03492333', 'acronym': 'GFD_IBS', 'briefTitle': 'Gluten Free Diet in IBS Patients Stratified According to Their Antigliadin Status', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'The Role of Antigliadin Antibodies in Predicting the Beneficial Effect of Gluten Free Diet in Unselected IBS Patients', 'orgStudyIdInfo': {'id': 'AGA_GFD_in_IBS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gluten free diet', 'description': 'Single arm', 'interventionNames': ['Other: Gluten free diet']}], 'interventions': [{'name': 'Gluten free diet', 'type': 'OTHER', 'description': 'Gluten-free diet- Instructions provided by a dietitian', 'armGroupLabels': ['Gluten free diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S4K1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Farncombe Institute', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Premysl Bercik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}