Administration of Oral Probiotic Streptococcus Salivarius K12: Oral Colonization, Impact on Oral Microbiome and Inflammatory Markers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Impact of Streptococcus salivarius K12 on oral colonization
研究概览
简要总结
The clinical trial is investigating the oral administration of probiotic Streptococcus salivarius K12 in the form of lozenges in healthy adults.
The main outcome measures are:
- Potential for Streptococcus salivarius K12 to colonise the oral cavity
- Effect on other bacteria and Candida albicans in the oral cavity
- Possible anti-inflammatory effect
Participants will:
- Take one lozenge containing Streptococcus salivarius K12 daily for 4 weeks
- Attend 3 dental check-ups (before starting the probiotic treatment, and after 4 and 8 weeks)
- Collect their own saliva samples in accordance with a sampling schedule
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Adults (> 18 years)
- •no caries or periodontal disease
排除标准
- •Within the last 4 weeks before the trial, intake of...
- •anti-inflammatory drugs
- •antimicrobial substances
- •probiotics
研究组 & 干预措施
BIOTICS-O
The study is designed with before-and-after controls.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Impact of Streptococcus salivarius K12 on oral colonization
时间窗: Baseline, intervention, and washout samples are collected according to a sampling schedule for 8 weeks.
Quantitative PCR (qPCR) for Streptococcus salivarius and BLIS-containing plasmid counts in saliva samples
Impact of Streptococcus salivarius K12 on oral colonization
时间窗: Three dental plaque samples are analysed: baseline, intervention (after 4 weeks), and washout (after 8 weeks)
Microbiome analysis of dental plaque samples (Bacteria, 16S rRNA gene sequencing)
Impact of Streptococcus salivarius K12 on oral colonization
时间窗: Three saliva samples are analysed: baseline, intervention (after 4 weeks), and washout (after 8 weeks)
Determination of Candida albicans load by culture from saliva samples
次要结局
- Impact of Streptococcus salivarius K12 on salivary immune markers(Baseline, intervention, and washout samples (saliva) are collected according to a sampling schedule for 8 weeks.)