Administration of Oral Probiotic Streptococcus Salivarius K12: Oral Colonization, Impact on Oral Microbiome and Inflammatory Markers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Zurich
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Impact of Streptococcus salivarius K12 on oral colonization
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
BIOTICS-O
The study is designed with before-and-after controls.
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
Impact of Streptococcus salivarius K12 on oral colonization
Time Frame: Baseline, intervention, and washout samples are collected according to a sampling schedule for 8 weeks.
Quantitative PCR (qPCR) for Streptococcus salivarius and BLIS-containing plasmid counts in saliva samples
Impact of Streptococcus salivarius K12 on oral colonization
Time Frame: Three dental plaque samples are analysed: baseline, intervention (after 4 weeks), and washout (after 8 weeks)
Microbiome analysis of dental plaque samples (Bacteria, 16S rRNA gene sequencing)
Impact of Streptococcus salivarius K12 on oral colonization
Time Frame: Three saliva samples are analysed: baseline, intervention (after 4 weeks), and washout (after 8 weeks)
Determination of Candida albicans load by culture from saliva samples
Secondary Outcomes
- Impact of Streptococcus salivarius K12 on salivary immune markers(Baseline, intervention, and washout samples (saliva) are collected according to a sampling schedule for 8 weeks.)