Administration of Oral Probiotic Streptococcus Salivarius K12

Administration of Oral Probiotic Streptococcus Salivarius K12: Oral Colonization, Impact on Oral Microbiome and Inflammatory Markers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07757360

Enrollment

Registered

2026-08-11

Start date

2026-05-06

Completion date

2026-08-01

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health

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

Interventions

DIETARY_SUPPLEMENTProbiotic

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Impact of Streptococcus salivarius K12 on oral colonization	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

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026