Microbial Colonization
Conditions
Keywords
Probiotic toothpaste, Streptococcus salivarius M18, microbial colonization, oral probiotic, toothpaste
Brief summary
The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in healthy adults
Detailed description
This is a double blind randomized controlled study with no cross over to evaluate the colonization efficacy of toothpaste containing a commercially available probiotic bacterium Streptococcus salivarius M18. Participants will be randomly assigned to one of the 3 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.
Interventions
OTHERStreptococcus salivarius M18 toothpaste
Probiotics Streptococcus salivarius M18 toothpaste 1 million cfu/g In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.
Sponsors
John Hale
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
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.
Intervention model description
Participants will be randomly assigned to one of the 3 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 Study Group A: BLIS M18 Toothpaste (1 Million Cfu/dose) (n = 10) Study Group B: BLIS M18 Toothpaste (10 Million Cfu/dose) (n = 10) Study Group C: BLIS M18 Toothpaste (100 Million Cfu/dose) (n = 10)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* In general good health * Practise good oral hygiene
Exclusion criteria
1. Have a history of autoimmune disease or are immunocompromised. 2. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week 3. History of allergy (e.g. dairy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Microbial colonization from baseline (Day 0) to 1 hour | 1 hour post intervention | Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism). |
| Change in Microbial colonization from baseline (Day 0) to 8 hours | 8 hours post intervention | Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism). |
| Change in Microbial colonization from baseline (Day 0) to 24 hours | 24 hours post intervention | Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism). |
| Change in Microbial colonization from baseline (Day 0) to 24 hours post last dose | 24 hours after last dose following 7 days of daily brushing with probiotic toothpaste. | Study will determine the change in the microbial colonization efficacy of three different doses of S. salivarius M18 in a toothpaste format. Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 in a toothpaste format. The saliva Statistical analysis (e.g. ANOVA) will be carried out to compare the participants data from baseline to one hour after later across three different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel, GraphPad Prism). |
Countries
New Zealand
Contacts
Primary ContactJohn D Hale, PhD
Backup ContactRohit Jain, PhD
Outcome results
None listed