The aim of this study is to evaluate the colonization efficacy of probiotic lozenges and powders containing specific prebiotics in healthy adults
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
60
In this study, a lozenge will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
Blis Technologies Ltd
Dunedin, Otago, New Zealand
RECRUITINGChange 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).
Time frame: 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).
Time frame: 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).
Time frame: 24 hour
Change in microbial colonization from baseline (Day 0) to 48 hours or S. salivarius K12 lozenges
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In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
In this study, a powder will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
In this study, a powder containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
In this study, a lozenge containing will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 48 hour