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临床试验/NCT04891523
NCT04891523已完成不适用

Dissecting Probiotic Modulation of Oral Microbiota in Healthy Individuals

Prof. Jacques SCHRENZEL2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年11月1日最近更新:
适应症

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

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

发起方
Prof. Jacques SCHRENZEL
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Jacques SCHRENZEL

Professor

University Hospital, Geneva

研究点 (2)

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