Dissecting Probiotic Modulation of Oral Microbiota in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Changes in the salivary cytokines levels following probiotics treatment
研究概览
简要总结
Targeting human microbiota, in particular those of the gastrointestinal tract, by means of prebiotics, probiotics, symbiotics or antibiotics has gained interest for its potential in the management of human health. Oral bacterial communities have been extensively studied over the last decade both in normal and pathological states; however, little data are available on the possibility to modify microbiota composition in a controlled and 'non-aggressive' manner by using probiotics, in order to improve oral health.
Saliva contains microorganisms attached to exfoliated human cells and released from oral biofilms; its microbiota is most similar (proportionally) to those of the dorsal and lateral tongue. In addition, bacteria belonging to genera Porphyromonas, Tannerella and Treponema, which contain species associated with periodontitis, are consistently identified in saliva. Salivary microbial communities are relatively stable and thus potentially interesting as an indicator of oral and general health. Indeed, it has been suggested that interventions aimed at improving oral health should target mucosal microbiota (to which saliva is most similar) in addition to dental microbial communities. Whole saliva also constitutes an alternative to gingival crevicular fluid when analysing analytes present in periodontal pockets. It has been suggested that saliva reflects a consensus inflammatory status of the whole mouth with potentially significant clinical relevance.
Strain K12 of Streptococcus salivarius is available internationally as a food supplement, notably for oral hygiene. Several studies investigated the effectiveness of S. salivarius as a probiotic in the context of pharyngeal infections, halitosis, plaque formation and caries. Our study will focus on the effects of supplementation with this commercially available oral probiotic on the resident microbiota and inflammatory markers in order to identify signatures associated with resistance/susceptibility to colonization by probiotic strains.
详细描述
OBJECTIVES
This is a monocentric, prospective, cross-over, randomized, double-blinded study in which all participants will receive placebo and active probiotic treatment, 15 of which will first be treated with placebo and then will be given probiotics. The other 15 participants will first get probiotics and then, after a 3-week wash out period, the placebo.
The main objective of the study is to assess changes in salivary microbiota profiles and inflammatory markers following S. salivarius probiotic treatment. Our secondary objective is to identify correlations between specific salivary microbial taxa (subspecies to phylum levels) and inflammatory markers. Clinical outcome is not the focus of this study, although basic information about the oral health will be measured.
METHODOLOGY
BIOTICS-O (Burgerstein) probiotic that will be used is a commercial food supplement available over the counter in the pharmacy as blister packs of 30 lozenges containing 10^9 CFU of S. salivarius K12. Participants will let melt the lozenge after tooth brushing in the evening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature
- •Good oral and general health
排除标准
- •Women who are pregnant or breast feeding
- •Intention to become pregnant during the course of the study
- •Systemic disease
- •Previous enrolment into the current study
- •Clinically diagnosed severe oral lesions
- •Use of antibiotics and topical oral probiotics within the 3 months preceding the study or during the study
- •Dental treatments and use of oral disinfectants within 30 days preceding the study or during the study
结局指标
主要结局
Changes in the salivary cytokines levels following probiotics treatment
时间窗: Will be assessed at the end of a three-week course of no treatment, probiotics or placebo
Wilcoxon test
Changes in the bacterial diversity (Shannon index)
时间窗: Will be assessed at the end of a three-week course of no treatment, probiotics or placebo
Wilcoxon test
Changes in the relative abundance of individual bacterial taxa following probiotics treatment
时间窗: Will be assessed at the end of a three-week course of no treatment, probiotics or placebo
ANCOM test
Changes in the overall taxonomic profiles of the salivary bacterial communities (microbiota) following probiotics treatment
时间窗: Will be assessed at the end of a three-week course of no treatment, probiotics or placebo
PERMANOVA test
Changes in the relative abundance of gene functions following probiotics treatment
时间窗: Will be assessed at the end of a three-week course of no treatment, probiotics or placebo
Wilcoxon test
Changes in the absolute abundance of individual bacterial taxa following probiotics treatment
时间窗: Will be assessed at the end of a three-week course of no treatment, probiotics or placebo
Wilcoxon test
次要结局
- Positive and negative correlations between overall bacterial community taxonomic profile and salivary cytokine levels(Will be assessed at weeks 1, 4, 7, 10, 13, 16, 19)
- Positive and negative correlations between salivary bacterial taxa and salivary cytokine levels(Will be assessed at weeks 1, 4, 7, 10, 13, 16, 19)
研究者
Prof. Jacques SCHRENZEL
Professor
University Hospital, Geneva
