Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Microbial colonization from baseline (Day 0) to 24 hours
研究概览
简要总结
The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in healthy adults
详细描述
This is a double blind randomized controlled study with no cross over to evaluate the colonization efficacy of toothpaste containing a commercially available probiotic bacterium Streptococcus salivarius M18.
Participants will be randomly assigned to one of the 3 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
A staff member not part of the study group will be assigned to distribute blinded samples. The participant or the investigators will not be aware of the dose groups.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In general good health
- •Practise good oral hygiene
排除标准
- •Have a history of autoimmune disease or are immunocompromised.
- •Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
- •History of allergy (e.g. dairy).
结局指标
主要结局
Change in Microbial colonization from baseline (Day 0) to 24 hours
时间窗: 24 hours post intervention
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).
Change in Microbial colonization from baseline (Day 0) to 1 hour
时间窗: 1 hour post intervention
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).
Change in Microbial colonization from baseline (Day 0) to 8 hours
时间窗: 8 hours post intervention
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).
Change in Microbial colonization from baseline (Day 0) to 24 hours post last dose
时间窗: 24 hours after last dose following 7 days of daily brushing with probiotic toothpaste.
Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism).
次要结局
未报告次要终点
研究者
John Hale
CTO
BLIS Technologies Limited