Microbial Colonization of Oral Probiotics

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 lozenges and powders containing specific prebiotics in healthy adults

Detailed Description
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This is a double-blind, randomized controlled colonization pilot study with no cross over to evaluate the colonization efficacy of lozenges and powders containing two different commercially available probiotic bacteria (S. salivarius K12 ) or S. salivarius M18 with or without 2 different prebiotic sugars or their combinations. Participants will be randomly assigned to one of the 12 groups consuming probiotic lozenge or powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotics (e.g. sugars that may promote probiotic activity) over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonisation efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Official Title
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Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius in the Oral Cavity

Conditions
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Microbial Colonization

Intervention / Treatment
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* Dietary Supplement: Streptococcus salivarius K12 lozenge
* Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic A
* Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic B
* Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotics A and B
* Dietary Supplement: Probiotic S. salivarius K12 powder
* Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic A
* Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic B
* Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotics A and B
* Dietary Supplement: Probiotic S. salivarius M18 lozenges
* Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic A
* Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic B
* Dietary Supplement: Probiotic S. salivarius M18 + lozenges containing prebiotic A and B


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or Female 18y - 80y age In general good health 18 - 80 years of age. Practice 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 12 groups consuming powder or lozenges containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotic: Probiotic S. salivarius K12 lozenges Probiotic S. salivarius K12 lozenges containing prebiotic A Probiotic S. salivarius K12 lozenges containing prebiotic B Probiotic S. salivarius K12 lozenges containing prebiotic A and B Probiotic S. salivarius K12 powder Probiotic S. salivarius K12 powder containing prebiotic A Probiotic S. salivarius K12 powder containing prebiotic B Probiotic S. salivarius K12 powder containing prebiotic A and B Probiotic S. salivarius M18 lozenges Probiotic S. salivarius M18 lozenges containing prebiotic A Probiotic S. salivarius M18 lozenges der containing prebiotic B Probiotic S. salivarius M18 + lozenges containing prebiotic A and B
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Streptococcus salivarius K12 lozenge<br>Streptococcus salivarius K12 lozenge | Dietary Supplement: Streptococcus salivarius K12 lozenge<br>* In this study, a lozenge will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.<br>|
| Active Comparator: Probiotic S. salivarius K12 lozenges containing prebiotic A<br>Streptococcus salivarius K12 lozenge with prebiotic | Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic A<br>* In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.<br>|
| Active Comparator: Probiotic S. salivarius K12 lozenges containing prebiotic B<br>Streptococcus salivarius K12 lozenge with prebiotic | Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic B<br>* In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.<br>|
| Active Comparator: Probiotic S. salivarius K12 lozenges containing prebiotic A and B<br>Streptococcus salivarius K12 | Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotics A and B<br>* In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.<br>|
| Active Comparator: Probiotic S. salivarius K12 powder<br>Streptococcus salivarius K12 powder | Dietary Supplement: Probiotic S. salivarius K12 powder<br>* In this study, a powder will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity<br>|
| Active Comparator: Probiotic S. salivarius K12 powder containing prebiotic A<br>Streptococcus salivarius K12 powder with prebiotic | Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic A<br>* In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity<br>|
| Active Comparator: Probiotic S. salivarius K12 powder containing prebiotic B<br>Streptococcus salivarius K12 powder with prebiotic | Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic B<br>* In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity<br>|
| Active Comparator: Probiotic S. salivarius K12 powder containing prebiotic A and B<br>Streptococcus salivarius K12 powder with prebiotic | Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotics A and B<br>* In this study, a powder containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity<br>|
| Active Comparator: Probiotic S. salivarius M18 lozenges<br>Streptococcus salivarius M18 lozenge | Dietary Supplement: Probiotic S. salivarius M18 lozenges<br>* In this study, a lozenge containing will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.<br>|
| Active Comparator: Probiotic S. salivarius M18 lozenges containing prebiotic A<br>Streptococcus salivarius M18 lozenge with prebiotic | Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic A<br>* In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.<br>|
| Active Comparator: Probiotic S. salivarius M18 lozenges der containing prebiotic B<br>Streptococcus salivarius M18 lozenge with prebiotic | Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic B<br>* In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.<br>|
| Active Comparator: Probiotic S. salivarius M18 + lozenges containing prebiotic A and B<br>Streptococcus salivarius M18 lozenge with prebiotic | Dietary Supplement: Probiotic S. salivarius M18 + lozenges containing prebiotic A and B<br>* In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 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 for S. salivarius K12 lozenges | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to one hour after later across 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). | 1 hour | 
| Change in microbial colonization from baseline (Day 0) to 8 hours or S. salivarius K12 lozenges | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to eight hours after later across 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). | 8 hour | 
| Change in microbial colonization from baseline (Day 0) to 24 hours or S. salivarius K12 lozenges | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hours after later across 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). | 24 hour | 
| Change in microbial colonization from baseline (Day 0) to 48 hours or S. salivarius K12 lozenges | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48hours after later across 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). | 48 hour | 
| in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 powder format | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The statistical analysis (e.g. Students t-test) 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). | 1 hour | 
| in microbial colonization from baseline (Day 0) to 8 hour for S. salivarius K12 powder format | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 8 hours 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). | 8 hours | 
| in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius K12 powder format | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hours 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). | 24 hours | 
| in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius K12 powder format | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius K12 with or without prebiotics from a powder format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hours 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). | 48 hours | 
| Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius M18 lozenges | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to one hour after later across 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). | 1 hour | 
| Change in microbial colonization from baseline (Day 0) to 8 hours for S. salivarius M18 lozenges | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 8 hour after later across 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). | 8 hour | 
| Change in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius M18 lozenges | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hour after later across 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). | 24 hour | 
| Change in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius M18 lozenges | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 with or without prebiotics from a lozenge format. The statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hour after later across 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). | 48 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Streptococcus salivarius M18, Streptococcus salivarius K12, Probiotic, microbial colonization, oral probiotic, lozenges, powder, prebiotic