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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/NCT05367518




Registration number
NCT05367518
Ethics application status
Date submitted
3/05/2022
Date registered
10/05/2022
Date last updated
10/05/2022

Titles & IDs
Public title
Colonisation Efficacy of Oral Probiotic Fast Melt Powder
Scientific title
Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius From a Fast Melt Powder Format to the Oral Cavity
Secondary ID [1] 0 0
BLTCT2022/1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Microbial Colonization 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)
Other interventions - 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)


Other interventions: 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.

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

Outcomes
Primary outcome [1] 0 0
Change in microbial colonization from baseline (Day 0) to 1 hour
Timepoint [1] 0 0
1 hours post intervention
Primary outcome [2] 0 0
Change in microbial colonization from baseline (Day 0) to 8 hours
Timepoint [2] 0 0
8 hours post intervention
Primary outcome [3] 0 0
Change in microbial colonization from baseline (Day 0) to 24 hours
Timepoint [3] 0 0
24 hours post intervention
Primary outcome [4] 0 0
Change in microbial colonization from baseline (Day 0) to 48 hours post last dose
Timepoint [4] 0 0
48 hours after last dosing following 7 days of daily administration of probiotic

Eligibility
Key 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
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
Basic Science
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/05/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2022
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
BLIS Technologies Limited
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05367518
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.
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
john.hale@blis.co.nz
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05367518