Effect of Probiotic Bacteria on Oral Candida in Frail Elderly

Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391532
• Other study ID #: 2010/618
• Status: Completed
• Phase: N/A
• First received: March 6, 2015
• Last updated: August 10, 2015
• Start date: September 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: June 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Candidiasis

Intervention

Dietary Supplement:
• L. reuteri DSM 17938/ATCC PTA
Ingestion of active lozenge twice daily for 12 weeks
• Placebo
Ingestion of placebo lozenge twice daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Secondary	Change in levels of dental plaque	Secondary Outcome Measures will be measured before and after the intervention period.	Baseline and 12 weeks.	No
Secondary	Changes in levels of gingival bleeding.	Secondary Outcome Measures will be measured before and after the intervention period.	Baseline and 12 weeks.	No