Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
Study NCT ID:
NCT06773650
Status:
RECRUITING
Last Update Posted:
2025-01-14
First Post:
2025-01-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation for Lactose Intolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007787', 'term': 'Lactose Intolerance'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 385}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of knowledge of the Italian population on lactose intolerance', 'timeFrame': '3 months', 'description': 'The aim of this protocol is to investigate through an anonymous online survey the knowledge of the Italian population on clinical, pathophysiological, diagnostic and therapeutic issues of lactose intolerance'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lactose Intolerant', 'Lactose Malabsorption', 'Lactose Intolerance']}, 'descriptionModule': {'briefSummary': 'Lactose intolerance (LI) is considered the clinical syndrome caused by lactose malabsorption (LM).\n\nIt is possible to identify four causes of lactase deficiency defining four different types of LM: primary (genetic), secondary (acquired), congenital (alactasia), and developmental (in premature infants, so reversible).\n\nThe aim of this protocol is to investigate through an anonymous online survey the knowledge of the Italian population on clinical, pathophysiological, diagnostic and therapeutic issues of lactose intolerance. Data collected will be divulgated through a publication for both people with IL and nutritionists, enriched with tables and flow charts, to improve the knowledge on lactose intolerance and to support people suffering from this condition. The results of this survey will guide subjects suspected of suffering from lactose intolerance towards a correct diagnosis and a better management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding Lactose Intolerance', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be adults (≥18 years of age)\n* Willingness to complete the online survey\n\nExclusion Criteria:\n\n* Subjects \\<18 years of age\n* Subjects not available to answer the online survey'}, 'identificationModule': {'nctId': 'NCT06773650', 'briefTitle': 'Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation for Lactose Intolerance', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Lactose Intolerance: a Guide to Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation', 'orgStudyIdInfo': {'id': 'UID 4675'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients completing online survey', 'description': 'The online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding Lactose Intolerance', 'interventionNames': ['Other: Completion of online survey']}], 'interventions': [{'name': 'Completion of online survey', 'type': 'OTHER', 'description': 'The online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding LI', 'armGroupLabels': ['Patients completing online survey']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Patrizia Gnagnarella', 'role': 'CONTACT', 'email': 'patrizia.gnagnarella@ieo.it', 'phone': '+390257489823'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Patrizia Gnagnarella', 'role': 'CONTACT', 'email': 'patrizia.gnagnarella@ieo.it', 'phone': '+390257489823'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}