The aim of this study is to evaluate the colonization efficacy of probiotic lozenges containing dairy and dairy free probiotic Streptococcus salivarius M18, in healthy adults
This is a double-blind, randomized controlled colonization pilot study with no cross over to evaluate the colonization efficacy of two different lozenges containing either dairy or dairy free probiotic bacteria Streptococcus salivarius M18. Participants will be randomly assigned to one of the 2 groups consuming probiotic lozenge containing dairy free Streptococcus salivarius M18 or dairy based 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
30
In this study, a lozenge formulation containing dairy based S. salivarius M18 will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
In this study, a lozenge formulation containing dairy free S. salivarius M18 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 of S. salivarius M18 from Day 0 (baseline) to 1 hour
Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva 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 post intervention
Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 8 hours
Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva 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: 8 hour post intervention
Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 24 hours
Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva 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: 24 hours post intervention
Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 48hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva 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: 48 hours post intervention
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 1 hour
Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva 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 post intervention
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 8 hour
Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva 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: 8 hour post intervention
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 24 hour
Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva 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: 24 hour post intervention
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 48 hour
Study will determine the change in microbial colonization efficacy of dairy based Streptococcus salivarius M18 in a Lozenge format. The saliva 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: 48 hour post intervention