Oral HealthNCT07757360
Administration of Oral Probiotic Streptococcus Salivarius K12
A study testing Probiotic in people with Oral Health, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 May 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Adults (> 18 years)
- no caries or periodontal disease
Who cannot join
- Within the last 4 weeks before the trial, intake of...
- anti-inflammatory drugs
- antimicrobial substances
- probiotics
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center for Dental Medicine
Zurich, Canton of Zurich, 8032
About this study
Official title: Administration of Oral Probiotic Streptococcus Salivarius K12: Oral Colonization, Impact on Oral Microbiome and Inflammatory Markers
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
- Conditions
- Oral Health
- Being tested
- Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Streptococcus salivarius K12
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 group | Role | What they receive |
|---|---|---|
| BIOTICS-O | Experimental | The study is designed with before-and-after controls. Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Streptococcus salivarius K12 on oral colonization
Quantitative PCR (qPCR) for Streptococcus salivarius and BLIS-containing plasmid counts in saliva samples
Measured: 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)
Measured: 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
Measured: Three saliva samples are analysed: baseline, intervention (after 4 weeks), and washout (after 8 weeks)
Secondary outcomes (1)
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
Measured: Baseline, intervention, and washout samples (saliva) are collected according to a sampling schedule for 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start6 May 2026
- Primary completion15 Jul 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757360
- Sponsor's protocol ID
- BASEC-Nr. 2025-02383
- Status last verified
- Nov 2026
- First submitted
- 10 Jun 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Oral Probiotic Streptococcus Salivarius K12: Oral Colonization, Impact on Oral Microbiome and Inflammatory Markers
- ClinicalTrials.gov ID
- NCT07757360
- Acronym / sponsor ID
- BASEC-Nr. 2025-02383
- Conditions
- Oral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIOTICS-O | Experimental | Dietary Supplement: ProbioticThe study is designed with before-and-after controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Adults (> 18 years)
- no caries or periodontal disease
Key exclusion criteria (4 listed)
- Within the last 4 weeks before the trial, intake of...
- anti-inflammatory drugs
- antimicrobial substances
- probiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: Streptococcus salivarius K12The 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. | Dietary supplement | BIOTICS-O |
Primary outcome
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
1 secondary outcome
Impact of Streptococcus salivarius K12 on salivary immune markers
Time frame: Baseline, intervention, and washout samples (saliva) are collected according to a sampling schedule for 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Oral Health, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.