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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05480020




Registration number
NCT05480020
Ethics application status
Date submitted
27/07/2022
Date registered
29/07/2022

Titles & IDs
Public title
Probiotic Toothpaste for Microbial Colonization
Scientific title
Colonisation Efficacy of Streptococcus Salivarius M18 Toothpaste
Secondary ID [1] 0 0
BLTCT2022/5
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
Other interventions - Streptococcus salivarius M18 toothpaste
Other interventions - Streptococcus salivarius M18 toothpaste

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

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

Active comparator: Streptococcus salivarius M18 toothpaste dose 3 - Streptococcus salivarius M18 toothpaste containing 100 million cfu/g


Other interventions: Streptococcus salivarius M18 toothpaste
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
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.

Other interventions: Streptococcus salivarius M18 toothpaste
Probiotics Streptococcus salivarius M18 toothpaste 100 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 24 hours post last dose
Timepoint [4] 0 0
24 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
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
Other
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2022
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John R Tagg, PhD
Address 0 0
Blis Technologies
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT05480020