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The aim of this study is to evaluate the colonization efficacy of probiotic lozenges and powders containing specific prebiotics in healthy adults
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Streptococcus salivarius K12 lozenge | Active Comparator | Streptococcus salivarius K12 lozenge |
|
| Probiotic S. salivarius K12 lozenges containing prebiotic A | Active Comparator | Streptococcus salivarius K12 lozenge with prebiotic |
|
| Probiotic S. salivarius K12 lozenges containing prebiotic B | Active Comparator | Streptococcus salivarius K12 lozenge with prebiotic |
|
| Probiotic S. salivarius K12 lozenges containing prebiotic A and B | Active Comparator | Streptococcus salivarius K12 |
|
| Probiotic S. salivarius K12 powder | Active Comparator | Streptococcus salivarius K12 powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Streptococcus salivarius K12 lozenge | Dietary Supplement | In this study, a lozenge will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 lozenges | 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). | 1 hour |
| Change in microbial colonization from baseline (Day 0) to 8 hours or S. salivarius K12 lozenges | 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). | 8 hour |
| Change in microbial colonization from baseline (Day 0) to 24 hours or S. salivarius K12 lozenges | 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). | 24 hour |
| Change in microbial colonization from baseline (Day 0) to 48 hours or S. salivarius K12 lozenges |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John D Hale, PhD | Contact | +6434740988 | john.hale@blis.co.nz | |
| Rohit Jain, PhD | Contact | +6434740988 | rohit.jain@blis.co.nz |
| Name | Affiliation | Role |
|---|---|---|
| John D Hale, PhD | Blis Technologies Ltd | Study Director |
| Rohit Jain, PhD | Blis Technologies Ltd, Dunedin, New Zealand | Principal Investigator |
| John R Tagg, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blis Technologies Ltd | Recruiting | Dunedin | Otago | 9012 | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17194838 | Background | 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. doi: 10.1128/AEM.02265-06. Epub 2006 Dec 28. | |
| 26781236 |
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Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.
Study report 3 months after the completion of the study.
Summary study report will be shared by Principal investigator upon request if not published in public literature.
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Participants will be randomly assigned to one of the 12 groups consuming powder or lozenges containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotic:
Probiotic S. salivarius K12 lozenges Probiotic S. salivarius K12 lozenges containing prebiotic A Probiotic S. salivarius K12 lozenges containing prebiotic B Probiotic S. salivarius K12 lozenges containing prebiotic A and B
Probiotic S. salivarius K12 powder Probiotic S. salivarius K12 powder containing prebiotic A Probiotic S. salivarius K12 powder containing prebiotic B Probiotic S. salivarius K12 powder containing prebiotic A and B
Probiotic S. salivarius M18 lozenges Probiotic S. salivarius M18 lozenges containing prebiotic A Probiotic S. salivarius M18 lozenges der containing prebiotic B Probiotic S. salivarius M18 + lozenges containing prebiotic A and B
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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.
| Probiotic S. salivarius K12 powder containing prebiotic A |
| Active Comparator |
Streptococcus salivarius K12 powder with prebiotic |
|
| Probiotic S. salivarius K12 powder containing prebiotic B | Active Comparator | Streptococcus salivarius K12 powder with prebiotic |
|
| Probiotic S. salivarius K12 powder containing prebiotic A and B | Active Comparator | Streptococcus salivarius K12 powder with prebiotic |
|
| Probiotic S. salivarius M18 lozenges | Active Comparator | Streptococcus salivarius M18 lozenge |
|
| Probiotic S. salivarius M18 lozenges containing prebiotic A | Active Comparator | Streptococcus salivarius M18 lozenge with prebiotic |
|
| Probiotic S. salivarius M18 lozenges der containing prebiotic B | Active Comparator | Streptococcus salivarius M18 lozenge with prebiotic |
|
| Probiotic S. salivarius M18 + lozenges containing prebiotic A and B | Active Comparator | Streptococcus salivarius M18 lozenge with prebiotic |
|
| Probiotic S. salivarius K12 lozenges containing prebiotic A | Dietary Supplement | In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity. |
|
| Probiotic S. salivarius K12 lozenges containing prebiotic B | Dietary Supplement | In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity. |
|
| Probiotic S. salivarius K12 lozenges containing prebiotics A and B | Dietary Supplement | In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity. |
|
| Probiotic S. salivarius K12 powder | Dietary Supplement | In this study, a powder will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity |
|
| Probiotic S. salivarius K12 powder containing prebiotic A | Dietary Supplement | In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity |
|
| Probiotic S. salivarius K12 powder containing prebiotic B | Dietary Supplement | In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity |
|
| Probiotic S. salivarius K12 powder containing prebiotics A and B | Dietary Supplement | In this study, a powder containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity |
|
| Probiotic S. salivarius M18 lozenges | Dietary Supplement | In this study, a lozenge containing will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity. |
|
| Probiotic S. salivarius M18 lozenges containing prebiotic A | Dietary Supplement | In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity. |
|
| Probiotic S. salivarius M18 lozenges containing prebiotic B | Dietary Supplement | In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity. |
|
| Probiotic S. salivarius M18 + lozenges containing prebiotic A and B | Dietary Supplement | In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity. |
|
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). |
| 48 hour |
| in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 powder format | 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). | 1 hour |
| in microbial colonization from baseline (Day 0) to 8 hour for S. salivarius K12 powder format | 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). | 8 hours |
| in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius K12 powder format | 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). | 24 hours |
| in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius K12 powder format | 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). | 48 hours |
| Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius M18 lozenges | 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). | 1 hour |
| Change in microbial colonization from baseline (Day 0) to 8 hours for S. salivarius M18 lozenges | 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). | 8 hour |
| Change in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius M18 lozenges | 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). | 24 hour |
| Change in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius M18 lozenges | 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). | 48 hour |
| Blis Technologies Ltd, Dunedin, New Zealand |
| Principal Investigator |
| 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. |
| 26855579 | Background | 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. |
| 23286823 | Background | 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. |
| 27920580 | Background | 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. doi: 10.2147/DHPS.S117214. eCollection 2016. |
| 27874935 | Background | 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. |
| 26491371 | Background | 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. |
| 32099975 | Background | 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 Apr 3;18(2):161-164. doi: 10.3290/j.ohpd.a43359. |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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