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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/NCT05375396




Registration number
NCT05375396
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 Dairy Free Oral Probiotics
Scientific title
Assessment of Colonization of Dairy Free Probiotic Bacterium Streptococcus Salivarius From Lozenges to the Oral Cavity
Secondary ID [1] 0 0
BLTCT2022/4
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 M18 lozenges
Other interventions - Streptococcus salivarius M18 dairy free lozenges

Active Comparator: Streptococcus salivarius M18 lozenges - Streptococcus salivarius M18 lozenges containing dairy based Streptococcus salivarius M18

Active Comparator: Streptococcus salivarius M18 dairy free lozenges - Streptococcus salivarius M18 lozenges containing dairy free Streptococcus salivarius M18


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

Other interventions: Streptococcus salivarius M18 dairy free lozenges
In this study, a lozenge formulation containing dairy free S. salivarius M18 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 of S. salivarius M18 from Day 0 (baseline) to 1 hour
Timepoint [1] 0 0
1 hour post intervention
Primary outcome [2] 0 0
Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 8 hours
Timepoint [2] 0 0
8 hour post intervention
Primary outcome [3] 0 0
Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 24 hours
Timepoint [3] 0 0
24 hours post intervention
Primary outcome [4] 0 0
Change in microbial colonization of S. salivarius M18 from Day 0 (baseline) to 48hours
Timepoint [4] 0 0
48 hours post intervention
Primary outcome [5] 0 0
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 1 hour
Timepoint [5] 0 0
1 hour post intervention
Primary outcome [6] 0 0
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 8 hour
Timepoint [6] 0 0
8 hour post intervention
Primary outcome [7] 0 0
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 24 hour
Timepoint [7] 0 0
24 hour post intervention
Primary outcome [8] 0 0
Change in microbial colonization of dairy free S. salivarius M18 from Day 0 (baseline) to 48 hour
Timepoint [8] 0 0
48 hour post intervention

Eligibility
Key inclusion criteria
Inclusion criteria:

Male or Female 18y - 80y age

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
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
1/06/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2022
Actual
Sample size
Target
30
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 evaluate the colonization efficacy of probiotic lozenges
containing dairy and dairy free probiotic Streptococcus salivarius M18, in healthy adults
Trial website
https://clinicaltrials.gov/ct2/show/NCT05375396
Trial related presentations / publications
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.
Burton JP, Wescombe PA, Macklaim JM, Chai MH, Macdonald K, Hale JD, Tagg J, Reid G, Gloor GB, Cadieux PA. Persistence of the oral probiotic Streptococcus salivarius M18 is dose dependent and megaplasmid transfer can augment their bacteriocin production and adhesion characteristics. PLoS One. 2013 Jun 13;8(6):e65991. doi: 10.1371/journal.pone.0065991. Print 2013.
Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.
Public notes

Contacts
Principal investigator
Name 0 0
John D 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/NCT05375396