Administration of Oral Probiotic Streptococcus Salivarius K12

N/AActive Not RecruitingNCT07757360

University of Zurich12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Oral Health

Interventions

ProbioticDIETARY_SUPPLEMENT

The intervention consists of daily consumption of 1 lozenge BIOTICS-O for 4 weeks. BIOTICS-O are probiotic lozenges from the manufacturer Burgerstein Vitamine. They contain viable Streptococcus salivarius K12 (BLIS® K12, ATCC BAA-1024), 1 billion colony-forming units (CFU) per lozenge. BIOTICS-O is a dietary supplement available over the counter in Swiss pharmacies.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers * Adults (\> 18 years) * no caries or periodontal disease Exclusion Criteria: Within the last 4 weeks before the trial, intake of... * anti-inflammatory drugs * antimicrobial substances * probiotics

Locations (1)

Center for Dental Medicine

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

Impact of Streptococcus salivarius K12 on oral colonization

Quantitative PCR (qPCR) for Streptococcus salivarius and BLIS-containing plasmid counts in saliva samples

Time frame: Baseline, intervention, and washout samples are collected according to a sampling schedule for 8 weeks.

Impact of Streptococcus salivarius K12 on oral colonization

Microbiome analysis of dental plaque samples (Bacteria, 16S rRNA gene sequencing)

Time frame: Three dental plaque samples are analysed: baseline, intervention (after 4 weeks), and washout (after 8 weeks)

Impact of Streptococcus salivarius K12 on oral colonization

Determination of Candida albicans load by culture from saliva samples

Time frame: Three saliva samples are analysed: baseline, intervention (after 4 weeks), and washout (after 8 weeks)

Secondary Outcomes

Impact of Streptococcus salivarius K12 on salivary immune markers

Determination of immune marker concentration (IL-1 beta, IL-6, IL-10, MMP-8, and TNF alpha) in saliva using the Luminex technology

Time frame: Baseline, intervention, and washout samples (saliva) are collected according to a sampling schedule for 8 weeks.

Data from ClinicalTrials.gov

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