Effect of Probiotic Bacteria on Oral Candida in Frail Elderly

August 10, 2015 updated by: Mette Rose Jørgensen, University of Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

215

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: L. reuteri DSM 17938/ATCC PTA
L. reuteri DSM 17938/ATCC PTA lozenges twice daily for 12 weeks
Dietary supplement: L. reuteri DSM 17938/ATCC PTA
Ingestion of active lozenge twice daily for 12 weeks
Placebo Comparator: Placebo
Placebo lozenges twice daily for 12 weeks
Dietary supplement: Placebo
Ingestion of placebo lozenge twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Study Director: Svante Twetman, Professor, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/618

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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