Effect of Probiotic Bacteria on Oral Candida in Frail Elderly

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02391532

Enrollment

215

Registered

2015-03-18

Start date

2013-09-30

Completion date

2015-06-30

Last updated

2015-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidiasis

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.

Interventions

DIETARY_SUPPLEMENTL. reuteri DSM 17938/ATCC PTA

Ingestion of active lozenge twice daily for 12 weeks

DIETARY_SUPPLEMENTPlacebo

Ingestion of placebo lozenge twice daily for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026