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Clinical Trials/NCT05375383
NCT05375383UnknownNot Applicable

Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius in the Oral Cavity

BLIS Technologies Limited2 sites in 1 country60 target enrollmentStarted: June 15, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
2
Primary Endpoint
Change in microbial colonization from baseline (Day 0) to 24 hours or S. salivarius K12 lozenges

Study Overview

Brief Summary

The aim of this study is to evaluate the colonization efficacy of probiotic lozenges and powders containing specific prebiotics in healthy adults

Detailed Description

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Masking Description

A staff member not part of the study group will be assigned to distribute blinded samples. The participant or the investigators will not be aware of the dose groups.

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in microbial colonization from baseline (Day 0) to 24 hours or S. salivarius K12 lozenges

Time Frame: 24 hour

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).

Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 lozenges

Time Frame: 1 hour

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).

Change in microbial colonization from baseline (Day 0) to 48 hours or S. salivarius K12 lozenges

Time Frame: 48 hour

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).

in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius K12 powder format

Time Frame: 48 hours

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).

Change in microbial colonization from baseline (Day 0) to 8 hours or S. salivarius K12 lozenges

Time Frame: 8 hour

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).

in microbial colonization from baseline (Day 0) to 8 hour for S. salivarius K12 powder format

Time Frame: 8 hours

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).

Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius M18 lozenges

Time Frame: 1 hour

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).

in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius K12 powder format

Time Frame: 24 hours

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).

in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 powder format

Time Frame: 1 hour

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).

Change in microbial colonization from baseline (Day 0) to 8 hours for S. salivarius M18 lozenges

Time Frame: 8 hour

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).

Change in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius M18 lozenges

Time Frame: 24 hour

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).

Change in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius M18 lozenges

Time Frame: 48 hour

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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