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The aim of this study is to test saliva samples obtained from healthy human participants for anti-viral activity after they have consumed S. salivarius probiotic in a powder format.
This is a randomized controlled open pilot study to evaluate saliva samples collected from participants following their consumption of powders containing the commercially marketed probiotic bacterium S. salivarius K12 or S. salivarius M18.
Participants will be randomly assigned to one of the 4 groups consuming probiotic powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotics (e.g. sugars that may promote probiotic activity). Saliva samples will be collected at predetermined time points pre and post intervention. Antibacterial and Antiviral activity will be determined following established assays. 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 | Active Comparator | Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g) |
|
| Streptococcus salivarius K12 with a prebiotic included | Active Comparator | Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g) |
|
| Streptococcus salivarius M18 | Active Comparator | Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g) |
|
| Streptococcus salivarius M18 with a prebiotic included | Active Comparator | Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Streptococcus salivarius K12 Powder 1 Billion colony forming units /g) | Dietary Supplement | Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as lozenges for local delivery in the oral cavity to provide oral health benefits. In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 3 hours | Study will determine the antiviral activity of Streptococcus salivarius K12 without prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and 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). | 3 hours post intervention |
| Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 8 hours | Study will determine the antiviral activity of Streptococcus salivarius K12 without prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and 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 post intervention |
| Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 3 hours | Study will determine the antiviral activity of Streptococcus salivarius K12 with prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and 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). |
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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 | |
| John R Tagg, PhD | Contact | 6434740988 | john.tagg@blis.co.nz |
| Name | Affiliation | Role |
|---|---|---|
| John D Hale, PhD | Blis Technologies Ltd, Dunedin, New Zealand | Study Director |
| John R Tagg, PhD | Blis Technologies Ltd, Dunedin, New Zealand | Principal Investigator |
| 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 information and information included in the protocol and the 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 4 groups consuming powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotic:
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|
| Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included | Dietary Supplement | In this study, a powder formulation containing Streptococcus salivarius K12 and a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity. |
|
| Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) | Dietary Supplement | In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity. |
|
| Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic included | Dietary Supplement | In this study, a powder formulation containing S. salivarius M18 and a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity. |
|
| 3 hours post intervention |
| Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 8 hours | Study will determine the antiviral activity of Streptococcus salivarius K12 with prebiotic in a powder format. The antiviral and antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and 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 post intervention |
| Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 3 hours | Study will determine the antibacterial activity of Streptococcus salivarius M18 without prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05. | 3 hours post intervention |
| Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 8 hours | Study will determine the antibacterial activity of Streptococcus salivarius M18 without prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05. | 8 hours post intervention |
| Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 3 hours | Study will determine the antibacterial activity of Streptococcus salivarius M18 with prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05. | 3 hours post intervention |
| Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 8 hours | Study will determine the antibacterial activity of Streptococcus salivarius M18 with prebiotic in a powder format. The antibacterial activity in the saliva will be determined using appropriate assays and Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data for different days (pre and post time points) and different formulations with the level of significance of p≤0.05. | 8 hours post intervention |
| Liam Harold, PhD |
| 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. |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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