跳至主要内容
临床试验/NCT02391532
NCT02391532已完成不适用

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

University of Copenhagen0 个研究点目标入组 215 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
215
主要终点
Prevalence of oral Candida growth assessed from chair-side tests.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non-smoking
  • ability to cooperate with a dental examination and saliva sampling

排除标准

  • severe chronic disease, malignancies or ongoing medication with immunosuppressive drugs
  • severe dementia or cognitive impairment

结局指标

主要结局

Prevalence of oral Candida growth assessed from chair-side tests.

时间窗: 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.

时间窗: Baseline and 12 weeks.

Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.

次要结局

  • Change in levels of dental plaque(Baseline and 12 weeks.)
  • Changes in levels of gingival bleeding.(Baseline and 12 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Rose Jørgensen

PhD Student

University of Copenhagen

相似试验