Back to resultsEffect of Probiotic Bacteria on Oral Candida in Frail Elderly
Primary Purpose
Candidiasis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
L. reuteri DSM 17938/ATCC PTA
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Candidiasis
Eligibility Criteria
Inclusion Criteria:
- non-smoking
- ability to cooperate with a dental examination and saliva sampling
Exclusion Criteria:
- severe chronic disease, malignancies or ongoing medication with immunosuppressive drugs
- severe dementia or cognitive impairment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
L. reuteri DSM 17938/ATCC PTA
Placebo
Arm Description
L. reuteri DSM 17938/ATCC PTA lozenges twice daily for 12 weeks
Placebo lozenges twice daily for 12 weeks
Outcomes
Primary Outcome Measures
Prevalence of oral Candida growth assessed from chair-side tests.
Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.
Amount of oral Candida growth assessed from chair-side tests.
Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.
Secondary Outcome Measures
Change in levels of dental plaque
Secondary Outcome Measures will be measured before and after the intervention period.
Changes in levels of gingival bleeding.
Secondary Outcome Measures will be measured before and after the intervention period.
Full Information
NCT ID
NCT02391532
First Posted
March 6, 2015
Last Updated
August 10, 2015
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02391532
Brief Title
Effect of Probiotic Bacteria on Oral Candida in Frail Elderly
Official Title
Effect of Probiotic Bacteria (L. Reuteri) on Oral Candida Counts in Frail Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L. reuteri DSM 17938/ATCC PTA
Arm Type
Active Comparator
Arm Description
L. reuteri DSM 17938/ATCC PTA lozenges twice daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo lozenges twice daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
L. reuteri DSM 17938/ATCC PTA
Intervention Description
Ingestion of active lozenge twice daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Ingestion of placebo lozenge twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Prevalence of oral Candida growth assessed from chair-side tests.
Description
Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.
Time Frame
Baseline and 12 weeks.
Title
Amount of oral Candida growth assessed from chair-side tests.
Description
Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.
Time Frame
Baseline and 12 weeks.
Secondary Outcome Measure Information:
Title
Change in levels of dental plaque
Description
Secondary Outcome Measures will be measured before and after the intervention period.
Time Frame
Baseline and 12 weeks.
Title
Changes in levels of gingival bleeding.
Description
Secondary Outcome Measures will be measured before and after the intervention period.
Time Frame
Baseline and 12 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
non-smoking
ability to cooperate with a dental examination and saliva sampling
Exclusion Criteria:
severe chronic disease, malignancies or ongoing medication with immunosuppressive drugs
severe dementia or cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svante Twetman, Professor
Organizational Affiliation
University of Copenhagen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
26202995
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.
Results Reference
derived
Learn more about this trial
Effect of Probiotic Bacteria on Oral Candida in Frail Elderly
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