Microbial Colonization of Oral Probiotics
Study Details
Study Description
Brief Summary
The aim of this study is to evaluate the colonization efficacy of probiotic lozenges and powders containing specific prebiotics in healthy adults
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Streptococcus salivarius K12 lozenge Streptococcus salivarius K12 lozenge |
Dietary Supplement: Streptococcus salivarius K12 lozenge
In this study, a lozenge will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
|
| Active Comparator: Probiotic S. salivarius K12 lozenges containing prebiotic A Streptococcus salivarius K12 lozenge with prebiotic |
Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic A
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
|
| Active Comparator: Probiotic S. salivarius K12 lozenges containing prebiotic B Streptococcus salivarius K12 lozenge with prebiotic |
Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic B
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
|
| Active Comparator: Probiotic S. salivarius K12 lozenges containing prebiotic A and B Streptococcus salivarius K12 |
Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotics A and B
In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
|
| Active Comparator: Probiotic S. salivarius K12 powder Streptococcus salivarius K12 powder |
Dietary Supplement: Probiotic S. salivarius K12 powder
In this study, a powder will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
|
| Active Comparator: Probiotic S. salivarius K12 powder containing prebiotic A Streptococcus salivarius K12 powder with prebiotic |
Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic A
In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
|
| Active Comparator: Probiotic S. salivarius K12 powder containing prebiotic B Streptococcus salivarius K12 powder with prebiotic |
Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic B
In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
|
| Active Comparator: Probiotic S. salivarius K12 powder containing prebiotic A and B Streptococcus salivarius K12 powder with prebiotic |
Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotics A and B
In this study, a powder containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity
|
| Active Comparator: Probiotic S. salivarius M18 lozenges Streptococcus salivarius M18 lozenge |
Dietary Supplement: Probiotic S. salivarius M18 lozenges
In this study, a lozenge containing will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
|
| Active Comparator: Probiotic S. salivarius M18 lozenges containing prebiotic A Streptococcus salivarius M18 lozenge with prebiotic |
Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic A
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
|
| Active Comparator: Probiotic S. salivarius M18 lozenges der containing prebiotic B Streptococcus salivarius M18 lozenge with prebiotic |
Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic B
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
|
| Active Comparator: Probiotic S. salivarius M18 + lozenges containing prebiotic A and B Streptococcus salivarius M18 lozenge with prebiotic |
Dietary Supplement: Probiotic S. salivarius M18 + lozenges containing prebiotic A and B
In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
|
Outcome Measures
Primary Outcome Measures
- Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 lozenges [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 8 hours or S. salivarius K12 lozenges [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).
- Change in microbial colonization from baseline (Day 0) to 24 hours or S. salivarius K12 lozenges [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 48 hours or S. salivarius K12 lozenges [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 1 hour for S. salivarius K12 powder format [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).
- in microbial colonization from baseline (Day 0) to 8 hour for S. salivarius K12 powder format [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).
- in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius K12 powder format [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 48 hours for S. salivarius K12 powder format [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 1 hour for S. salivarius M18 lozenges [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).
- Change in microbial colonization from baseline (Day 0) to 8 hours for S. salivarius M18 lozenges [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 [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 [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).
Eligibility Criteria
Criteria
Inclusion criteria:
-
Male or Female 18y - 80y age
-
In general good health 18 - 80 years of age.
-
Practice good oral hygiene.
Exclusion criteria:
-
Have a history of autoimmune disease or are immunocompromised.
-
Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
-
History of allergy (e.g. dairy).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Blis Technologies Ltd | Dunedin | Otago | New Zealand | 9012 |
Sponsors and Collaborators
- BLIS Technologies Limited
Investigators
- Study Director: John D Hale, PhD, Blis Technologies Ltd
- Principal Investigator: Rohit Jain, PhD, Blis Technologies Ltd, Dunedin, New Zealand
- Principal Investigator: John R Tagg, PhD, Blis Technologies Ltd, Dunedin, New Zealand
Study Documents (Full-Text)
None provided.More Information
Publications
- Bardellini E, Amadori F, Gobbi E, Ferri A, Conti G, Majorana A. Does Streptococcus Salivarius Strain M18 Assumption Make Black Stains Disappear in Children? Oral Health Prev Dent. 2020;18(1):161-164. doi: 10.3290/j.ohpd.a43359.
- Burton JP, Chilcott CN, Wescombe PA, Tagg JR. Extended Safety Data for the Oral Cavity Probiotic Streptococcus salivarius K12. Probiotics Antimicrob Proteins. 2010 Oct;2(3):135-44. doi: 10.1007/s12602-010-9045-4.
- Di Pierro F, Adami T, Rapacioli G, Giardini N, Streitberger C. Clinical evaluation of the oral probiotic Streptococcus salivarius K12 in the prevention of recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes in adults. Expert Opin Biol Ther. 2013 Mar;13(3):339-43. doi: 10.1517/14712598.2013.758711. Epub 2013 Jan 4.
- Di Pierro F, Colombo M, Giuliani MG, Danza ML, Basile I, Bollani T, Conti AM, Zanvit A, Rottoli AS. Effect of administration of Streptococcus salivarius K12 on the occurrence of streptococcal pharyngo-tonsillitis, scarlet fever and acute otitis media in 3 years old children. Eur Rev Med Pharmacol Sci. 2016 Nov;20(21):4601-4606.
- Di Pierro F, Colombo M, Zanvit A, Rottoli AS. Positive clinical outcomes derived from using Streptococcus salivarius K12 to prevent streptococcal pharyngotonsillitis in children: a pilot investigation. Drug Healthc Patient Saf. 2016 Nov 21;8:77-81. eCollection 2016.
- Di Pierro F, Zanvit A, Nobili P, Risso P, Fornaini C. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study. Clin Cosmet Investig Dent. 2015 Oct 3;7:107-13. doi: 10.2147/CCIDE.S93066. eCollection 2015.
- Gregori G, Righi O, Risso P, Boiardi G, Demuru G, Ferzetti A, Galli A, Ghisoni M, Lenzini S, Marenghi C, Mura C, Sacchetti R, Suzzani L. Reduction of group A beta-hemolytic streptococcus pharyngo-tonsillar infections associated with use of the oral probiotic Streptococcus salivarius K12: a retrospective observational study. Ther Clin Risk Manag. 2016 Jan 19;12:87-92. doi: 10.2147/TCRM.S96134. eCollection 2016.
- Hyink O, Wescombe PA, Upton M, Ragland N, Burton JP, Tagg JR. Salivaricin A2 and the novel lantibiotic salivaricin B are encoded at adjacent loci on a 190-kilobase transmissible megaplasmid in the oral probiotic strain Streptococcus salivarius K12. Appl Environ Microbiol. 2007 Feb;73(4):1107-13. Epub 2006 Dec 28.
- BLTCT2022/3