Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT01867151
Status:
UNKNOWN
Last Update Posted:
2013-06-03
First Post:
2013-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002054', 'term': 'Burning Mouth Syndrome'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic 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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-31', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-05-31', 'lastUpdatePostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oral pain', 'timeFrame': '28 days', 'description': 'oral pain will be evaluated by means of visual analogue scales'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '28 days', 'description': 'quality of life of patients with BMS will be evaluated by means of SF36 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Burning Mouth Syndrome', 'Gluten', 'Gluten Free Diet'], 'conditions': ['Burning Mouth Syndrome']}, 'descriptionModule': {'briefSummary': 'Gluten free diet (GFD) is now being tested in patients affected by schizophrenia, autism and multiple sclerosis, making GFD a possible therapeutic weapon not only for celiac disease or gluten sensitivity. In this protocol we investigate the effect of GFD in patients affected by burning mouth syndrome (BMS), a disease of unknown origin characterized by oral and especially tongue burning sensation, deeply decreasing the quality of life of patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Primary BMS\n\nExclusion Criteria:\n\n* Celiac Disease\n* Psychiatric Disorders\n* intestinal autoimmune diseases\n* Ongoing cancer'}, 'identificationModule': {'nctId': 'NCT01867151', 'briefTitle': 'Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Effetto Della Dieta Priva di Glutine in Soggetti Con BMS', 'orgStudyIdInfo': {'id': 'BMS2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gluten free diet', 'description': 'BMS patients following a GFD', 'interventionNames': ['Dietary Supplement: Gluten Free Diet']}, {'type': 'SHAM_COMPARATOR', 'label': 'Normal Diet', 'description': 'Patients with BMS maintaing a normal diet', 'interventionNames': ['Dietary Supplement: Normal Diet']}], 'interventions': [{'name': 'Gluten Free Diet', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Gluten free diet']}, {'name': 'Normal Diet', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Normal Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'facility': "Fondazione IRCCS Ca' Granda", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Luca Elli, MD', 'role': 'CONTACT', 'email': 'dottorlucaelli@gmail.com', 'phone': '00390255033384'}], 'overallOfficials': [{'name': 'Luca Elli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Cà Granda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Scientific Director', 'investigatorFullName': 'Prof. Pier Mannuccio Mannucci', 'investigatorAffiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}}}}