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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Assessment of Anti-viral Activity of Saliva Obtained From Human Volunteers Following Application of Probiotic Streptococcus Salivarius to the Oral Cavity
Secondary ID [1] 0 0
BLTCT2022/2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower Respiratory Tract Infection 0 0
Upper Respiratory Tract Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Streptococcus salivarius K12 Powder 1 Billion colony forming units /g)
Treatment: Other - Streptococcus salivarius K12 Powder (1 Billion colony forming units /g) with a prebiotic included
Treatment: Other - Streptococcus salivarius M18 Powder (1 Billion colony forming units /g)
Treatment: Other - 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)


Treatment: Other: 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.

Treatment: Other: 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.

Treatment: Other: 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.

Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 3 hours
Timepoint [1] 0 0
3 hours post intervention
Primary outcome [2] 0 0
Change in antiviral activity following dosing with probiotic S. salivarius K12 in saliva from Day 0 (baseline) to 8 hours
Timepoint [2] 0 0
8 hours post intervention
Primary outcome [3] 0 0
Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 3 hours
Timepoint [3] 0 0
3 hours post intervention
Primary outcome [4] 0 0
Change in antiviral activity following dosing with probiotic S. salivarius K12 with prebiotic in saliva from Day 0 (baseline) to 8 hours
Timepoint [4] 0 0
8 hours post intervention
Primary outcome [5] 0 0
Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 3 hours
Timepoint [5] 0 0
3 hours post intervention
Primary outcome [6] 0 0
Change in antiviral activity following dosing with probiotic S. salivarius M18 in saliva from Day 0 (baseline) to 8 hours
Timepoint [6] 0 0
8 hours post intervention
Primary outcome [7] 0 0
Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 3 hours
Timepoint [7] 0 0
3 hours post intervention
Primary outcome [8] 0 0
Change in antiviral activity following dosing with probiotic S. salivarius M18 with prebiotic in saliva from Day 0 (baseline) to 8 hours
Timepoint [8] 0 0
8 hours post intervention

Eligibility
Key inclusion criteria
Inclusion criteria:

1. In general good health 18 - 80 years of age.
2. Practice good oral hygiene.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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).

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
23/05/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/08/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Otago

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
John Hale
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05374070
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.
Public notes

Contacts
Principal investigator
Name 0 0
John D Hale, PhD
Address 0 0
Blis Technologies Ltd, Dunedin, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
John D Hale, PhD
Address 0 0
Country 0 0
Phone 0 0
6434740988
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05374070