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Completed

NCT Number: NCT02391532

Effect of Probiotic Bacteria on Oral Candida 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.

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Key information

Conditions

Candidiasis Bacterial Infections and Mycoses Infections Mycoses

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L. reuteri DSM 17938/ATCC PTA

Dietary Supplement

Ingestion of active lozenge twice daily for 12 weeks

Placebo

Dietary Supplement

Ingestion of placebo lozenge twice daily for 12 weeks

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in levels of dental plaque

    Time frame: Baseline and 12 weeks.

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

  2. Changes in levels of gingival bleeding.

    Time frame: Baseline and 12 weeks.

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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Mar 18, 2015
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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