Probiotic Toothpaste to Assess Microbial Colonization

Study Overview
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Brief Summary
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The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in healthy adults

Detailed Description
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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 2 groups for brushing teeth with a probiotic toothpaste containing two 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.

Official Title
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Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste

Conditions
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Microbial Colonization

Intervention / Treatment
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* Other: Streptococcus salivarius M18 toothpaste (1 million cfu)
* Other: Streptococcus salivarius M18 toothpaste (10 million cfu)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In general good health Practise good oral hygiene Exclusion Criteria:- Have a history of autoimmune disease or are immunocompromised. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week History of allergy (e.g. dairy).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of the 2 groups for brushing teeth with a probiotic toothpaste containing different doses of Streptococcus salivarius M18 Study Group A: BLIS M18 Toothpaste (10 million Cfu/dose) (n = 10) Study Group B: BLIS M18 Toothpaste (1 Million Cfu/dose) (n = 10)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: Streptococcus salivarius M18 toothpaste dose 1<br>Streptococcus salivarius M18 toothpaste containing 1 million cfu/g | Other: Streptococcus salivarius M18 toothpaste (1 million cfu)<br>* 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.<br>|
| Active Comparator: Active Comparator: Streptococcus salivarius M18 toothpaste dose 2<br>Streptococcus salivarius M18 toothpaste containing 10 million cfu/g | Other: Streptococcus salivarius M18 toothpaste (10 million cfu)<br>* Probiotics Streptococcus salivarius M18 toothpaste 10 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Microbial colonization from baseline (Day 0) to 1 hour | Study will determine the change in the microbial colonization efficacy of two 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). | 1 hour post intervention | 
| Change in Microbial colonization from baseline (Day 0) to 8 hours | 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). | 8 hours post intervention | 
| Change in Microbial colonization from baseline (Day 0) to 24 hours | 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 two 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). | 24 hours post intervention | 
| Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose | Study will determine the change in the microbial colonization efficacy of two 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). | 8 hours after last dose following 7 days of daily brushing with probiotic toothpaste. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic toothpaste, Streptococcus salivarius M18, Microbial colonization, Oral Probiotic, Toothpaste