Effect of Probiotic Bacteria on Oral Candida in Frail Elderly

Not Applicable

Completed

• Conditions: Candidiasis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: L. reuteri DSM 17938/ATCC PTA

• Registration Number: NCT02391532
• Lead Sponsor: University of Copenhagen

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 Timeline

• Study Start: 2013-09
• Primary Completion: 2014-03
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-18
• Study Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo lozenges twice daily for 12 weeks
L. reuteri DSM 17938/ATCC PTA	L. reuteri DSM 17938/ATCC PTA	L. reuteri DSM 17938/ATCC PTA lozenges twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Prevalence of oral Candida growth assessed from chair-side tests.	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.	Baseline and 12 weeks.	Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.

Secondary Outcome Measures

Name	Time	Method
Change in levels of dental plaque	Baseline and 12 weeks.	Secondary Outcome Measures will be measured before and after the intervention period.
Changes in levels of gingival bleeding.	Baseline and 12 weeks.	Secondary Outcome Measures will be measured before and after the intervention period.