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| ID | Type | Description | Link |
|---|---|---|---|
| 2025EXP24497 | Other Identifier | Health and Disabilities Ethics Committee MOH Wellington NZ |
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The aim of this study is to evaluate efficacy of a probiotic lozenge containing BLIS M18, BLIS K12 and a prebiotic in healthy adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral probiotic lozenges | Active Comparator | Oral probiotic lozenges containing Streptococcus salivarius M18 and Streptococcus salivarius K12 and prebiotic |
|
| Placebo lozenges | Placebo Comparator | Oral lozenges |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 13 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John D Hale, PhD | Contact | +6434740988 | john.hale@blis.co.nz | |
| Rohit Jain, PhD | Contact | +6434740988 | rohit.jain@blis.co.nz |
| Name | Affiliation | Role |
|---|---|---|
| John R Tagg, PhD | BLIS Technologies Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blis Technologies Ltd | Dunedin | Otago | 9012 | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23449874 | Background | 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. |
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Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.
Study report 3 months after the completion of the study
Summary study report will be shared by Principal Investigator upon request if not published in public literature
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| ID | Term |
|---|---|
| D006209 | Halitosis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A staff member not part of the study group will be assigned to distribute blinded samples. The participant or the investigators will not be aware of the dose groups.
|
| Placebo | Other | Probiotic free placebo lozenge |
|