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Effect of Probiotic Bacteria on Oral Candida in Frail Elderly

Sponsor
University of Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT02391532
Collaborator
(none)
215
Enrollment
2
Arms
21
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: L. reuteri DSM 17938/ATCC PTA
  • Dietary Supplement: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
215 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Effect of Probiotic Bacteria (L. Reuteri) on Oral Candida Counts in Frail Elderly
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. Change in levels of dental plaque [Baseline and 12 weeks.]

    Secondary Outcome Measures will be measured before and after the intervention period.

  2. Changes in levels of gingival bleeding. [Baseline and 12 weeks.]

    Secondary Outcome Measures will be measured before and after the intervention period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Copenhagen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mette Rose Jørgensen, PhD Student, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT02391532
Other Study ID Numbers:
  • 2010/618
First Posted:
Mar 18, 2015
Last Update Posted:
Aug 11, 2015
Last Verified:
Aug 1, 2015
Additional relevant MeSH terms:
Candidiasis

Study Results

No Results Posted as of Aug 11, 2015