Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-04-07 @ 7:10 PM
Study NCT ID:
NCT02391532
Status:
COMPLETED
Last Update Posted:
2015-08-11
First Post:
2015-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotic Bacteria on Oral Candida in Frail Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002177', 'term': 'Candidiasis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-10', 'studyFirstSubmitDate': '2015-03-06', 'studyFirstSubmitQcDate': '2015-03-12', 'lastUpdatePostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of oral Candida growth assessed from chair-side tests.', 'timeFrame': 'Baseline and 12 weeks.', 'description': 'Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.'}, {'measure': 'Amount of oral Candida growth assessed from chair-side tests.', 'timeFrame': 'Baseline and 12 weeks.', 'description': 'Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.'}], 'secondaryOutcomes': [{'measure': 'Change in levels of dental plaque', 'timeFrame': 'Baseline and 12 weeks.', 'description': 'Secondary Outcome Measures will be measured before and after the intervention period.'}, {'measure': 'Changes in levels of gingival bleeding.', 'timeFrame': 'Baseline and 12 weeks.', 'description': 'Secondary Outcome Measures will be measured before and after the intervention period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Candidiasis']}, 'referencesModule': {'references': [{'pmid': '26202995', 'type': 'DERIVED', 'citation': 'Kraft-Bodi E, Jorgensen MR, Keller MK, Kragelund C, Twetman S. Effect of Probiotic Bacteria on Oral Candida in Frail Elderly. J Dent Res. 2015 Sep;94(9 Suppl):181S-6S. doi: 10.1177/0022034515595950. Epub 2015 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of daily intake of the probiotic Lactobacillus Reuteri on the prevalence and counts of oral Candida in frail elderly living in nursery homes.', 'detailedDescription': 'The aim of the present study was to investigate the effect of a twice daily intake of lozenges containing probiotic Lactobacillus reuteri on the prevalence and counts of oral Candida in senior residents living in nursery homes. The material consists of 215 elderly persons (range 60 to 102 years) living in 20 different nursery homes in the County of Kronoberg, situated in the southern parts of Sweden. The subjects were consecutively enrolled after informed consent consisting of verbal and written information directed to the individual as well as to their relatives. The study employed a double-blind randomized placebo-controlled design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-smoking\n* ability to cooperate with a dental examination and saliva sampling\n\nExclusion Criteria:\n\n* severe chronic disease, malignancies or ongoing medication with immunosuppressive drugs\n* severe dementia or cognitive impairment'}, 'identificationModule': {'nctId': 'NCT02391532', 'briefTitle': 'Effect of Probiotic Bacteria on Oral Candida in Frail Elderly', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effect of Probiotic Bacteria (L. Reuteri) on Oral Candida Counts in Frail Elderly', 'orgStudyIdInfo': {'id': '2010/618'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'L. reuteri DSM 17938/ATCC PTA', 'description': 'L. reuteri DSM 17938/ATCC PTA lozenges twice daily for 12 weeks', 'interventionNames': ['Dietary Supplement: L. reuteri DSM 17938/ATCC PTA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo lozenges twice daily for 12 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'L. reuteri DSM 17938/ATCC PTA', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of active lozenge twice daily for 12 weeks', 'armGroupLabels': ['L. reuteri DSM 17938/ATCC PTA']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of placebo lozenge twice daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Svante Twetman, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Mette Rose Jørgensen', 'investigatorAffiliation': 'University of Copenhagen'}}}}