Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-02 @ 7:32 AM
Study NCT ID:
NCT00844766
Status:
WITHDRAWN
Last Update Posted:
2019-04-04
First Post:
2009-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Home-screening Test 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': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study was stopped as no patient asked to participate was prepared to do so', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2009-02-13', 'studyFirstSubmitQcDate': '2009-02-13', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Lactose intolerance', 'Lactose', 'Home-screening test', 'Validate'], 'conditions': ['Lactose Intolerance']}, 'descriptionModule': {'briefSummary': 'The hypothesis underlying this study is that whilst there is no home-screening test for lactose intolerance, this test would have significant value as lactose tolerance tests and breath hydrogen tests are expensive and time consuming. Therefore, it would be highly beneficial to validate a simple home-screening test.\n\nThis study will validate a simple home-screening test that uses lactose and not milk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with lactose intolerance', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed lactose intolerance as demonstrated by a lactose tolerance test\n* Diagnosed as not having lactose intolerance as demonstrated by a lactose tolerance test\n\nExclusion Criteria:\n\n* Pregnant\n* Breastfeeding\n* Unwillingness to comply with study outline'}, 'identificationModule': {'nctId': 'NCT00844766', 'briefTitle': 'Validation of a Home-screening Test for Lactose Intolerance', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals, Leicester'}, 'officialTitle': 'A Study to Validate a Home-screening Test for Lactose Intolerant People', 'orgStudyIdInfo': {'id': 'UHL 10268'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'John F Mayberry, DSc MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals, Leicester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals, Leicester', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Carolyn Burden', 'oldOrganization': 'University Hospitals of Leicester NHS Trust'}}}}