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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05367518
Registration number
NCT05367518
Ethics application status
Date submitted
3/05/2022
Date registered
10/05/2022
Titles & IDs
Public title
Colonisation Efficacy of Oral Probiotic Fast Melt Powder
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Scientific title
Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius From a Fast Melt Powder Format to the Oral Cavity
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Secondary ID [1]
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BLTCT2022/1
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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:
Microbial Colonization
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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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0
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)
Treatment: Other - Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)
Active comparator: Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g - Probiotic Streptococcus salivarius K12 Fast Melt Powder (Dose 1: 1 Billion colony forming units /g)
Active comparator: Streptococcus salivarius K12 Fast Melt Powder 100 million colony forming units /g - Group B: Dose 2 Streptococcus salivarius K12 Fast Melt Powder (Dose 2: 100 Million colony forming unit/gram)
Treatment: Other: Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)
Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable tablet (lozenge) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt Powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
Treatment: Other: Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)
Probiotic Streptococcus salivarius K12 products are commercially available in traditional formats such as chewable table (lozenges) for local delivery in the oral cavity to provide oral health benefits. In this study, a Fast Melt Powder formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.
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Intervention code [1]
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Treatment: Other
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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 microbial colonization from baseline (Day 0) to 1 hour
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Assessment method [1]
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Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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).
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Timepoint [1]
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1 hours post intervention
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Primary outcome [2]
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Change in microbial colonization from baseline (Day 0) to 8 hours
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Assessment method [2]
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Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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).
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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 microbial colonization from baseline (Day 0) to 24 hours
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Assessment method [3]
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Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva 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).
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Timepoint [3]
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24 hours post intervention
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Primary outcome [4]
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Change in microbial colonization from baseline (Day 0) to 48 hours post last dose
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Assessment method [4]
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Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hours after last dosing across two different formulations over 7 days, 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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48 hours after last dosing following 7 days of daily administration of probiotic
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Eligibility
Key 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
Years
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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
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
Other
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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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
15/05/2022
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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
30/06/2022
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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
BLIS Technologies Limited
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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
To evaluate the colonisation efficacy (i.e. ability of the probiotic bacteria to remain in your mouth) of a fast melt powder that quickly dissolves in the mouth. The fast melt powder will contain a Streptococcus salivarius probiotic and the study is to be done in healthy adults.
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Trial website
https://clinicaltrials.gov/study/NCT05367518
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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. 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. 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, 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. 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.
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.
Supporting document/s available: Study protocol, Clinical study report (CSR)
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When will data be available (start and end dates)?
Study protocol, consent form before trail start. Study report 3 months after the completion of the study.
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Available to whom?
Summary study report will be shared by Principal investigator upon request if not published in public literature.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05367518