Halitosis
Conditions
Keywords
oral probiotic, halitosis, Streptococcus salivarius M18, Streptococcus salivarius K12, chewable tablet
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTIn this study, a probiotic lozenge formulation containing S. salivarius K12, M18 and prebiotic will be evaluated for its potential to improve bad breath
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.
OTHERPlacebo
Probiotic free placebo lozenge
Sponsors
John Hale
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants should be otherwise healthy, * practice good oral hygiene, * 18 - 70 years of age
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Volatile Sulphur Compounds in ppb between the active and placebo groups | 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 |
Countries
New Zealand
Contacts
CONTACTJohn D Hale, PhD
CONTACTRohit Jain, PhD
PRINCIPAL_INVESTIGATORJohn R Tagg, PhD
BLIS Technologies Ltd
Outcome results
None listed