Trial Review

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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/NCT06015958




Registration number
NCT06015958
Ethics application status
Date submitted
23/08/2023
Date registered
29/08/2023
Date last updated
29/08/2023

Titles & IDs
Public title
Probiotic Toothpaste to Assess Microbial Colonization
Scientific title
Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste
Secondary ID [1] 0 0
BLTCT2022/9
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 toothpaste (1 million cfu)
Other interventions - Streptococcus salivarius M18 toothpaste (10 million cfu)

Active Comparator: Active Comparator: Streptococcus salivarius M18 toothpaste dose 1 - Streptococcus salivarius M18 toothpaste containing 1 million cfu/g

Active Comparator: Active Comparator: Streptococcus salivarius M18 toothpaste dose 2 - Streptococcus salivarius M18 toothpaste containing 10 million cfu/g


Other interventions: Streptococcus salivarius M18 toothpaste (1 million cfu)
Probiotics Streptococcus salivarius M18 toothpaste 1 million cfu/g
In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic to the oral cavity.

Other interventions: Streptococcus salivarius M18 toothpaste (10 million cfu)
Probiotics Streptococcus salivarius M18 toothpaste 10 million cfu/g
In this study, a toothpaste formulation containing S. salivarius M18 will be evaluated for its potential for delivering the probiotic 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 hour 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 8 hours post last dose
Timepoint [4] 0 0
8 hours after last dose following 7 days of daily brushing with probiotic toothpaste.

Eligibility
Key inclusion criteria
- In general good health

- Practise good oral hygiene
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-

- Have a history of autoimmune disease or are immunocompromised.

- Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week

- 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


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

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2024
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
The aim of this study is to evaluate the colonization efficacy of probiotic toothpastes in
healthy adults
Trial website
https://clinicaltrials.gov/ct2/show/NCT06015958
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06015958