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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
20
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.
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.
Blis Technologies Ltd
Dunedin, Otago, New Zealand
RECRUITINGChange 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 48 hours past last dose following 7 days of twice daily administration of probiotic.