Effect of Probiotic Bacteria on Oral Candida in Frail Elderly

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Probiotic Bacteria (L. Reuteri) on Oral Candida Counts in Frail Elderly

Conditions
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Candidiasis

Intervention / Treatment
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* Dietary Supplement: L. reuteri DSM 17938/ATCC PTA
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L. reuteri DSM 17938/ATCC PTA<br>L. reuteri DSM 17938/ATCC PTA lozenges twice daily for 12 weeks | Dietary Supplement: L. reuteri DSM 17938/ATCC PTA<br>* Ingestion of active lozenge twice daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo lozenges twice daily for 12 weeks | Dietary Supplement: Placebo<br>* Ingestion of placebo lozenge twice daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 12 weeks. | 
| 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. | Baseline and 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in levels of dental plaque | Secondary Outcome Measures will be measured before and after the intervention period. | Baseline and 12 weeks. | 
| Changes in levels of gingival bleeding. | Secondary Outcome Measures will be measured before and after the intervention period. | Baseline and 12 weeks. |