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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05374070
Registration number
NCT05374070
Ethics application status
Date submitted
9/05/2022
Date registered
13/05/2022
Date last updated
13/05/2022
Titles & IDs
Public title
Antiviral Activity of Oral Probiotics
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Scientific title
Assessment of Anti-viral Activity of Saliva Obtained From Human Volunteers Following Application of Probiotic Streptococcus Salivarius to the Oral Cavity
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Secondary ID [1]
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BLTCT2022/2
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lower Respiratory Tract Infection
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Upper Respiratory Tract Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Streptococcus salivarius K12 Powder 1 Billion colony forming units /g)
Other interventions - Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included
Other interventions - Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)
Other interventions - Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic included
Active Comparator: Streptococcus salivarius K12 - Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g)
Active Comparator: Streptococcus salivarius K12 with a prebiotic included - Streptococcus salivarius K12 (Dose 1: 1 Billion colony forming units /g)
Active Comparator: Streptococcus salivarius M18 - Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g)
Active Comparator: Streptococcus salivarius M18 with a prebiotic included - Streptococcus salivarius M18 (Dose 1: 1 Billion colony forming units /g)
Other interventions: Streptococcus salivarius K12 Powder 1 Billion colony forming units /g)
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.
Other interventions: Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included
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.
Other interventions: Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)
In this study, a powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
Other interventions: Streptococcus salivarius M18 Powder (1 Billion colony forming units /g) with a prebiotic included
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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 3 hours
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Assessment method [1]
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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).
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Timepoint [1]
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3 hours post intervention
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Primary outcome [2]
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Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 8 hours
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Assessment method [2]
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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).
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Timepoint [2]
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8 hours post intervention
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Primary outcome [3]
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Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 3 hours
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Assessment method [3]
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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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Timepoint [3]
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3 hours post intervention
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Primary outcome [4]
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Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 8 hours
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Assessment method [4]
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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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Timepoint [4]
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8 hours post intervention
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Primary outcome [5]
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Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 3 hours
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Assessment method [5]
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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.
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Timepoint [5]
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3 hours post intervention
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Primary outcome [6]
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Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 8 hours
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Assessment method [6]
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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.
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Timepoint [6]
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8 hours post intervention
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Primary outcome [7]
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Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 3 hours
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Assessment method [7]
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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.
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Timepoint [7]
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3 hours post intervention
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Primary outcome [8]
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Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 8 hours
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Assessment method [8]
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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.
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Timepoint [8]
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8 hours post intervention
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. In general good health 18 - 80 years of age.
2. Practice good oral hygiene.
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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).
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
23/05/2022
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/08/2022
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Otago
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
John Hale
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05374070
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Trial related presentations / publications
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.
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.
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Public notes
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Contacts
Principal investigator
Name
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John D Hale, PhD
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Address
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Blis Technologies Ltd, Dunedin, New Zealand
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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John D Hale, PhD
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Address
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Country
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Phone
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6434740988
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05374070
Download to PDF