Microbial Colonization
Conditions
Keywords
Streptococcus salivarius M18, dairy free, allergen free, probiotic, microbial colonization, oral probiotic, chewable tablet
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.
Interventions
DIETARY_SUPPLEMENTStreptococcus salivarius M18 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.
DIETARY_SUPPLEMENTStreptococcus salivarius M18 dairy free lozenges
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.
Sponsors
John Hale
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, 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.
Intervention model description
Probiotic Streptococcus salivarius M18 lozenges Probiotics dairy free Streptococcus salivarius M18 lozenges
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Male or Female 18y - 80y age 1. In general good health 18 - 80 years of age. 2. Practice good oral hygiene.
Exclusion criteria
1. Have a history of autoimmune disease or are immunocompromised. 2. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week 3. History of allergy (e.g. dairy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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 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). |
Countries
New Zealand
Contacts
Primary ContactJohn D Hale, PhD
Backup ContactRohit Jain, PhD
Outcome results
None listed