Probiotic Modulation of Oral Microbiota

NCT04891523 | Completed

• 1 other identifier: 320030_197598
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (6)

• Changes in the overall taxonomic profiles of the salivary bacterial communities (microbiota) following probiotics treatment

  PERMANOVA test

  Will be assessed at the end of a three-week course of no treatment, probiotics or placebo

• Changes in the relative abundance of individual bacterial taxa following probiotics treatment

  ANCOM test

  Will be assessed at the end of a three-week course of no treatment, probiotics or placebo

• Changes in the absolute abundance of individual bacterial taxa following probiotics treatment

  Wilcoxon test

  Will be assessed at the end of a three-week course of no treatment, probiotics or placebo

• Changes in the relative abundance of gene functions following probiotics treatment

  Wilcoxon test

  Will be assessed at the end of a three-week course of no treatment, probiotics or placebo

• Changes in the bacterial diversity (Shannon index)

  Wilcoxon test

  Will be assessed at the end of a three-week course of no treatment, probiotics or placebo

• Changes in the salivary cytokines levels following probiotics treatment

  Wilcoxon test

  Will be assessed at the end of a three-week course of no treatment, probiotics or placebo

Secondary Outcomes (2)

• 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

Study Arms (2)

Placebo-Probiotic

OTHER

First receive placebo, then active probiotics.

Dietary Supplement: Probiotics-O (Burgerstein); Other: Placebo [inactivated Probiotics-O (Burgerstein)]

Probiotic-Placebo

OTHER

First receive active probiotics, then placebo.

Dietary Supplement: Probiotics-O (Burgerstein); Other: Placebo [inactivated Probiotics-O (Burgerstein)]

Interventions

Probiotics-O (Burgerstein) DIETARY_SUPPLEMENT

Topical oral treatment with the probiotic Streptococcus salivarius K12 (BIOTICS-O, Burgerstein) in form of a lozenge, daily, during 3 weeks.

Placebo-Probiotic; Probiotic-Placebo

Placebo [inactivated Probiotics-O (Burgerstein)] OTHER

Topical oral treatment with the placebo \[inactivated probiotic Streptococcus salivarius K12 (BIOTICS-O, Burgerstein)\] in form of a lozenge, daily, during 3 weeks.

Placebo-Probiotic; Probiotic-Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent as documented by signature
• Good oral and general health

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Jacques SCHRENZEL: lead

Study Sites (1)

Geneva University Hospitals (HUG)

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 18, 2021
• Study Start: November 1, 2021
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

CH (1)