HalitosisNCT07384130
Oral Probiotics for Halitosis in Healthy Adults
A study testing In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath in people with Halitosis, run by John Hale at 1 site in New Zealand.
Trial summary
The aim of this study is to evaluate efficacy of a probiotic lozenge containing BLIS M18, BLIS K12 and a prebiotic in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNew Zealand
- Study dates
- 15 Mar 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants should be otherwise healthy,
- practice good oral hygiene,
- 18 - 70 years of age
Who cannot join
- on antibiotic therapy,
- immunocompromised (have a weakened immune system)
- history of autoimmune disease,
- allergy or sensitivity to dairy,
- have an active periodontal disease, any known allergy or sensitivity to components of the test product or cysteine solution.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Oral Probiotics on Cysteine-Induced Halitosis in Healthy Adult Volunteers.
The aim of this study is to evaluate efficacy of a probiotic lozenge containing BLIS M18, BLIS K12 and a prebiotic in healthy adults.
Read the detailed description
This is a double-blind, randomized controlled colonization pilot study with no crossover to evaluate the efficacy of probiotic lozenges on halitosis in healthy adults.
Participants will be randomly assigned to 2 groups consuming probiotic lozenge containing Streptococcus salivarius M18 and K12 and with prebiotic over a 13 day period. Breath scores will be measured at predetermined time points pre and post intervention.
- Conditions
- Halitosis
- Being tested
- In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath, Placebo
- Keywords
- oral probiotic, halitosis, Streptococcus salivarius M18, Streptococcus salivarius K12, chewable tablet
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breathDietary supplement
In this study, a probiotic-free lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath as a comparator.
PlaceboOther
Probiotic free placebo lozenge
| Study group | Role | What they receive |
|---|---|---|
| Oral probiotic lozenges | Active comparator | Oral probiotic lozenges containing Streptococcus salivarius M18 and Streptococcus salivarius K12 and prebiotic Receives: Dietary Supplement: In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath |
| Placebo lozenges | Placebo comparator | Oral lozenges Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Volatile Sulphur Compounds in ppb between the active and placebo groups
Study will determine the change in Volatile Sulphur Compounds (VSCs) as measured in ppb, following application of probiotic lozenges containing Streptococcus salivarius K12, Streptococcus salivarius M18 and prebiotic compared with a placebo lozenge. Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to post cysteine mouthrinse before the lozenge application and 13 days after once a day lozenge application with the level of significance of p≤0.05 across the probiotic and placebo lozenge. Appropriate statistical analysis software (e.g. Microsoft Excel) will be used to analyse the data
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HalitosisStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Hale
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, John Hale, BLIS Technologies Limited
- Investigators
- John R Tagg, PhD, Principal investigator, BLIS Technologies Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384130
- Sponsor's protocol ID
- BLTCT2025/1
- Other IDs
- 2025EXP24497
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.
Publications
Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.
PubMed 23449874
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Probiotics on Cysteine-Induced Halitosis in Healthy Adult Volunteers.
- ClinicalTrials.gov ID
- NCT07384130
- Acronym / sponsor ID
- BLTCT2025/1
- Conditions
- Halitosis
- Keywords
- oral probiotic, halitosis, Streptococcus salivarius M18, Streptococcus salivarius K12, chewable tablet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- John HaleIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 3 Feb 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 aim of this study is to evaluate efficacy of a probiotic lozenge containing BLIS M18, BLIS K12 and a prebiotic in healthy adults.
Detailed description
This is a double-blind, randomized controlled colonization pilot study with no crossover to evaluate the efficacy of probiotic lozenges on halitosis in healthy adults.
Participants will be randomly assigned to 2 groups consuming probiotic lozenge containing Streptococcus salivarius M18 and K12 and with prebiotic over a 13 day period. Breath scores will be measured at predetermined time points pre and post intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral probiotic lozenges | Active comparator | Dietary Supplement: In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breathOral probiotic lozenges containing Streptococcus salivarius M18 and Streptococcus salivarius K12 and prebiotic |
| Placebo lozenges | Placebo comparator | Other: PlaceboOral lozenges |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants should be otherwise healthy,
- practice good oral hygiene,
- 18 - 70 years of age
Key exclusion criteria (5 listed)
- on antibiotic therapy,
- immunocompromised (have a weakened immune system)
- history of autoimmune disease,
- allergy or sensitivity to dairy,
- have an active periodontal disease, any known allergy or sensitivity to components of the test product or cysteine solution.
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 |
|---|---|---|
| In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breathIn this study, a probiotic-free lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath as a comparator. | Dietary supplement | Oral probiotic lozenges |
| PlaceboProbiotic free placebo lozenge | Other | Placebo lozenges |
Primary outcome
Measurement of Volatile Sulphur Compounds in ppb between the active and placebo groups
Time frame: 13 days
Study will determine the change in Volatile Sulphur Compounds (VSCs) as measured in ppb, following application of probiotic lozenges containing Streptococcus salivarius K12, Streptococcus salivarius M18 and prebiotic compared with a placebo lozenge. Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to post cysteine mouthrinse before the lozenge application and 13 days after once a day lozenge application with the level of significance of p≤0.05 across the probiotic and placebo lozenge. Appropriate statistical analysis software (e.g. Microsoft Excel) will be used to analyse the data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 23449874Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.
- Individual participant dataSharing planned: Yes. Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.
Related trials for Halitosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment.
Periodontal Diseases, Oral Halitosis
Active, not recruiting
Effects of Green Tea Mouthwash on Halitosis, Periodontal Health, and Stress in Orthodontic Patients
Halitosis, Periodontal Health
RecruitingPhase 2
Effectiveness of Aquamin® in Mitigating Halitosis
Healthy, Halitosis
Not yet recruiting
Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults
Oral Malodor (Halitosis), Oral Dryness
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.
John R Tagg, PhD principal investigator
BLIS Technologies Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath in people with Halitosis, run by John Hale at 1 site in New Zealand.
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 5 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: opening soon, as of the sponsor's last update on 4 Feb 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 New Zealand. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John D Hale, PhD (+6434740988, john.hale@blis.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Volatile Sulphur Compounds in ppb between the active and placebo groups (time frame: 13 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07384130, which also lists 1 linked publication.
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 4 Feb 2026.