Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05375383




Registration number
NCT05375383
Ethics application status
Date submitted
11/05/2022
Date registered
16/05/2022
Date last updated
16/05/2022

Titles & IDs
Public title
Microbial Colonization of Oral Probiotics
Scientific title
Assessment of Colonisation of Probiotic Bacterium Streptococcus Salivarius in the Oral Cavity
Secondary ID [1] 0 0
BLTCT2022/3
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 - Streptococcus salivarius K12 lozenge
Other interventions - Probiotic S. salivarius K12 lozenges containing prebiotic A
Other interventions - Probiotic S. salivarius K12 lozenges containing prebiotic B
Other interventions - Probiotic S. salivarius K12 lozenges containing prebiotics A and B
Other interventions - Probiotic S. salivarius K12 powder
Other interventions - Probiotic S. salivarius K12 powder containing prebiotic A
Other interventions - Probiotic S. salivarius K12 powder containing prebiotic B
Other interventions - Probiotic S. salivarius K12 powder containing prebiotics A and B
Other interventions - Probiotic S. salivarius M18 lozenges
Other interventions - Probiotic S. salivarius M18 lozenges containing prebiotic A
Other interventions - Probiotic S. salivarius M18 lozenges containing prebiotic B
Other interventions - Probiotic S. salivarius M18 + lozenges containing prebiotic A and B

Active Comparator: Streptococcus salivarius K12 lozenge - Streptococcus salivarius K12 lozenge

Active Comparator: Probiotic S. salivarius K12 lozenges containing prebiotic A - Streptococcus salivarius K12 lozenge with prebiotic

Active Comparator: Probiotic S. salivarius K12 lozenges containing prebiotic B - Streptococcus salivarius K12 lozenge with prebiotic

Active Comparator: Probiotic S. salivarius K12 lozenges containing prebiotic A and B - Streptococcus salivarius K12

Active Comparator: Probiotic S. salivarius K12 powder - Streptococcus salivarius K12 powder

Active Comparator: Probiotic S. salivarius K12 powder containing prebiotic A - Streptococcus salivarius K12 powder with prebiotic

Active Comparator: Probiotic S. salivarius K12 powder containing prebiotic B - Streptococcus salivarius K12 powder with prebiotic

Active Comparator: Probiotic S. salivarius K12 powder containing prebiotic A and B - Streptococcus salivarius K12 powder with prebiotic

Active Comparator: Probiotic S. salivarius M18 lozenges - Streptococcus salivarius M18 lozenge

Active Comparator: Probiotic S. salivarius M18 lozenges containing prebiotic A - Streptococcus salivarius M18 lozenge with prebiotic

Active Comparator: Probiotic S. salivarius M18 lozenges der containing prebiotic B - Streptococcus salivarius M18 lozenge with prebiotic

Active Comparator: Probiotic S. salivarius M18 + lozenges containing prebiotic A and B - Streptococcus salivarius M18 lozenge with prebiotic


Other interventions: Streptococcus salivarius K12 lozenge
In this study, a lozenge will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.

Other interventions: Probiotic S. salivarius K12 lozenges containing prebiotic A
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.

Other interventions: Probiotic S. salivarius K12 lozenges containing prebiotic B
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.

Other interventions: Probiotic S. salivarius K12 lozenges containing prebiotics A and B
In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity.

Other interventions: Probiotic S. salivarius K12 powder
In this study, a powder will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity

Other interventions: Probiotic S. salivarius K12 powder containing prebiotic A
In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity

Other interventions: Probiotic S. salivarius K12 powder containing prebiotic B
In this study, a powder containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity

Other interventions: Probiotic S. salivarius K12 powder containing prebiotics A and B
In this study, a powder containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius K12 to the oral cavity

Other interventions: Probiotic S. salivarius M18 lozenges
In this study, a lozenge containing will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.

Other interventions: Probiotic S. salivarius M18 lozenges containing prebiotic A
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.

Other interventions: Probiotic S. salivarius M18 lozenges containing prebiotic B
In this study, a lozenge containing a prebiotic will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.

Other interventions: Probiotic S. salivarius M18 + lozenges containing prebiotic A and B
In this study, a lozenge containing two prebiotics will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 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 for S. salivarius K12 lozenges
Timepoint [1] 0 0
1 hour
Primary outcome [2] 0 0
Change in microbial colonization from baseline (Day 0) to 8 hours or S. salivarius K12 lozenges
Timepoint [2] 0 0
8 hour
Primary outcome [3] 0 0
Change in microbial colonization from baseline (Day 0) to 24 hours or S. salivarius K12 lozenges
Timepoint [3] 0 0
24 hour
Primary outcome [4] 0 0
Change in microbial colonization from baseline (Day 0) to 48 hours or S. salivarius K12 lozenges
Timepoint [4] 0 0
48 hour
Primary outcome [5] 0 0
in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius K12 powder format
Timepoint [5] 0 0
1 hour
Primary outcome [6] 0 0
in microbial colonization from baseline (Day 0) to 8 hour for S. salivarius K12 powder format
Timepoint [6] 0 0
8 hours
Primary outcome [7] 0 0
in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius K12 powder format
Timepoint [7] 0 0
24 hours
Primary outcome [8] 0 0
in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius K12 powder format
Timepoint [8] 0 0
48 hours
Primary outcome [9] 0 0
Change in microbial colonization from baseline (Day 0) to 1 hour for S. salivarius M18 lozenges
Timepoint [9] 0 0
1 hour
Primary outcome [10] 0 0
Change in microbial colonization from baseline (Day 0) to 8 hours for S. salivarius M18 lozenges
Timepoint [10] 0 0
8 hour
Primary outcome [11] 0 0
Change in microbial colonization from baseline (Day 0) to 24 hours for S. salivarius M18 lozenges
Timepoint [11] 0 0
24 hour
Primary outcome [12] 0 0
Change in microbial colonization from baseline (Day 0) to 48 hours for S. salivarius M18 lozenges
Timepoint [12] 0 0
48 hour

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Male or Female 18y - 80y age

2. In general good health 18 - 80 years of age.

3. 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
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
15/06/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/09/2022
Actual
Sample size
Target
60
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
The aim of this study is to evaluate the colonization efficacy of probiotic lozenges and
powders containing specific prebiotics in healthy adults
Trial website
https://clinicaltrials.gov/ct2/show/NCT05375383
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.
Di Pierro F, Zanvit A, Nobili P, Risso P, Fornaini C. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study. Clin Cosmet Investig Dent. 2015 Oct 3;7:107-13. doi: 10.2147/CCIDE.S93066. eCollection 2015.
Bardellini E, Amadori F, Gobbi E, Ferri A, Conti G, Majorana A. Does Streptococcus Salivarius Strain M18 Assumption Make Black Stains Disappear in Children? Oral Health Prev Dent. 2020 Apr 3;18:161-164. doi: 10.3290/j.ohpd.a43359.
Public notes

Contacts
Principal investigator
Name 0 0
John D Hale, PhD
Address 0 0
Blis Technologies Ltd
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/NCT05375383