Microbial Colonization
Conditions
Keywords
Streptococcus salivarius K12, Oral Probiotic, Fast Melt Powder
Brief summary
To evaluate the colonisation efficacy (i.e. ability of the probiotic bacteria to remain in your mouth) of a fast melt powder that quickly dissolves in the mouth. The fast melt powder will contain a Streptococcus salivarius probiotic and the study is to be done in healthy adults.
Detailed description
This is a double-blind, randomized controlled study with no cross over to evaluate the colonization efficacy of fast melt powders containing a commercially available probiotic bacterium Streptococcus salivarius K12. Participants will be randomly assigned to one of the 2 groups consuming Fast Melt powder containing two different doses of Streptococcus salivarius K12 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_SUPPLEMENTProbiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)
Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable tablet (lozenge) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt Powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
DIETARY_SUPPLEMENTProbiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)
Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable table (lozenges) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt Powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
Sponsors
BLIS Technologies Limited
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
Participants will be randomly assigned to one of the 2 groups consuming Fast Melt powder containing two different doses of Streptococcus salivarius K12 : Group A: Probiotic Streptococcus salivarius K12 Fast Melt Powder (Dose 1: 1 Billion colony forming unit/gram) Group B: Streptococcus salivarius K12 Fast Melt Powder (Dose 2: 100 Million colony forming unit/gram)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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 from baseline (Day 0) to 1 hour | 1 hours post intervention | Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder 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 from baseline (Day 0) to 8 hours | 8 hours post intervention | Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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 24 hours | 24 hours post intervention | Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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). |
| Change in microbial colonization from baseline (Day 0) to 48 hours post last dose | 48 hours after last dosing following 7 days of daily administration of probiotic | Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hours after last dosing across two different formulations over 7 days, 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 ContactJohn R Tagg, PhD
Outcome results
None listed