Microbial Colonization
Conditions
Brief summary
To evaluate the colonization efficacy (the ability of a probiotic bacteria to remain in the mouth) delivered in a chewing gum format. The chewing gum contains Streptococcus salivarius probiotic and the study is to be done in health adults.
Detailed description
This is a single blind, randomized controlled study to evaluate the colonization effectiveness of a chewing gum containing a commercially available probiotic bacterium. Participants will be randomly assigned to one of the two groups consuming chewing gum containing Streptococcus salivarius M18 over a 7-day period. Saliva samples will be collected at pre determined points (pre and post intervention). Colonization efficacy will be determined by enumerating the probiotic from the saliva samples using standard microbiological techniques.
Interventions
DIETARY_SUPPLEMENTStreptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)
Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
DIETARY_SUPPLEMENTStreptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)
Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
Sponsors
BLIS Technologies Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Masking description
A Staff member, not part of the study group will be assigned to distribute blinded samples. The investigator will not be are of the dose groups.
Intervention model description
Participants will be randomly assigned to one of two groups consuming chewing gum containing Streptococcus salivarius M18. Group A: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 5 minutes duration. Group B: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 10-20 minutes
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* In general, good health * Practice good oral hygiene
Exclusion criteria
* Have a history of autoimmune disease or are immune compromised. * Are on concurrent antibiotic therapy, or regular antibiotic use within last one week * People with allergies or sensitivities to dairy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Microbial colonization from baseline (Day 0) to 1 hour. | 1 hour post intervention. | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 1 hour across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. |
| 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 Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. |
| Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose. | 8 hours past last dose following 7 days of twice daily administration of probiotic. | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. |
| Change in Microbial colonization from baseline (Day 0) to 48 hours post last dose. | 48 hours past last dose following 7 days of twice daily administration of probiotic. | Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 48 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. |
Countries
New Zealand
Contacts
Primary ContactJohn D Hale, PhD
Backup ContactRohit Jain, PhD
Outcome results
None listed