Colonisation Efficacy of a Probiotic Chewing Gum.

Study Overview
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Brief Summary
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To evaluate the colonization efficacy (the ability of a probiotic bacteria to remain in the mouth) delivered in a chewing gum format. The chewing gum contains Streptococcus salivarius probiotic and the study is to be done in health adults.

Detailed Description
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This is a single blind, randomized controlled study to evaluate the colonization effectiveness of a chewing gum containing a commercially available probiotic bacterium. Participants will be randomly assigned to one of the two groups consuming chewing gum containing Streptococcus salivarius M18 over a 7-day period. Saliva samples will be collected at pre determined points (pre and post intervention). Colonization efficacy will be determined by enumerating the probiotic from the saliva samples using standard microbiological techniques.

Official Title
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Colonisation Efficacy of a Probiotic Chewing Gum.

Conditions
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Microbial Colonization

Intervention / Treatment
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* Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)
* Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In general, good health Practice good oral hygiene Exclusion Criteria: Have a history of autoimmune disease or are immune compromised. Are on concurrent antibiotic therapy, or regular antibiotic use within last one week People with allergies or sensitivities to 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 two groups consuming chewing gum containing Streptococcus salivarius M18. Group A: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 5 minutes duration. Group B: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 10-20 minutes
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes<br>Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 5 minutes duration. | Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)<br>* Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.<br>|
| Active Comparator: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 10 minutes<br>Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 10 minutes duration. | Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)<br>* Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation 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. | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 1 hour across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. | 1 hour post intervention. | 
| Change in Microbial colonization from baseline (Day 0) to 8 hours. | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. | 8 hours post intervention. | 
| Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose. | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. | 8 hours past last dose following 7 days of twice daily administration of probiotic. | 
| Change in Microbial colonization from baseline (Day 0) to 48 hours post last dose. | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 48 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. | 48 hours past last dose following 7 days of twice daily administration of probiotic. |