An interventional study of Streptococcus salivarius M18 lozenges and Streptococcus salivarius M18 dairy free lozenges in Microbial Colonization, sponsored by John Hale. Status unknown at 1 site in New Zealand. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-16.
Sponsored by John Hale · Not applicable, Interventional, and Basic science
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.
4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.
This study's planned enrollment of 30 is below the median of 122 across 2,718 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →John Hale is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Male or Female 18y - 80y age
Exclusion criteria:
Streptococcus salivarius M18 lozenges containing dairy based Streptococcus salivarius M18
Dietary Supplement: Streptococcus salivarius M18 lozenges
Streptococcus salivarius M18 lozenges containing dairy free Streptococcus salivarius M18
Dietary Supplement: Streptococcus salivarius M18 dairy free lozenges
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.
Change 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
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
Plan to share: Yes — Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.
Supporting information: Study protocol, Csr
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