Microbial Colonization of Dairy Free Oral Probiotics

Not Applicable

• Conditions: Microbial Colonization
• Interventions: Dietary Supplement: Streptococcus salivarius M18 lozenges; Dietary Supplement: Streptococcus salivarius M18 dairy free lozenges

• Registration Number: NCT05375396
• Lead Sponsor: John Hale

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Last Update Submitted: 2022-05-11
• Study First Posted: 2022-05-16
• Last Update Posted: 2022-05-16
• Study Start: 2022-06-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Streptococcus salivarius M18 lozenges	Streptococcus salivarius M18 lozenges	Streptococcus salivarius M18 lozenges containing dairy based Streptococcus salivarius M18
Streptococcus salivarius M18 dairy free lozenges	Streptococcus salivarius M18 dairy free lozenges	Streptococcus salivarius M18 lozenges containing dairy free Streptococcus salivarius M18

Primary Outcome Measures

Name	Time	Method
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 1 hour	1 hour post intervention	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).
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 8 hour	8 hour post intervention	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).
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 24 hour	24 hour post intervention	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).
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 48 hour	48 hour post intervention	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).
Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 1 hour	1 hour post intervention	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).
Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 24 hours	24 hours post intervention	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).
Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 48hours	48 hours post intervention	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).
Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 8 hours	8 hour post intervention	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).

Trial Locations

Locations (1)

Blis Technologies Ltd; 🇳🇿 Dunedin, Otago, New Zealand