Effect of Probiotic Bacteria (L. Reuteri) on Oral Candida Counts in Frail Elderly
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 215
- Primary Endpoint
- Prevalence of oral Candida growth assessed from chair-side tests.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
L. reuteri DSM 17938/ATCC PTA
L. reuteri DSM 17938/ATCC PTA lozenges twice daily for 12 weeks
Intervention: L. reuteri DSM 17938/ATCC PTA (Dietary Supplement)
Placebo
Placebo lozenges twice daily for 12 weeks
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Prevalence of oral Candida growth assessed from chair-side tests.
Time Frame: Baseline and 12 weeks.
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.
Time Frame: Baseline and 12 weeks.
Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.
Secondary Outcomes
- Change in levels of dental plaque(Baseline and 12 weeks.)
- Changes in levels of gingival bleeding.(Baseline and 12 weeks.)
Investigators
Mette Rose Jørgensen
PhD Student
University of Copenhagen