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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05375383
Ethics application status
Date submitted
11/05/2022
Date registered
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
Treatment: Other - Streptococcus salivarius K12 lozenge
Treatment: Other - Probiotic S. salivarius K12 lozenges containing prebiotic A
Treatment: Other - Probiotic S. salivarius K12 lozenges containing prebiotic B
Treatment: Other - Probiotic S. salivarius K12 lozenges containing prebiotics A and B
Treatment: Other - Probiotic S. salivarius K12 powder
Treatment: Other - Probiotic S. salivarius K12 powder containing prebiotic A
Treatment: Other - Probiotic S. salivarius K12 powder containing prebiotic B
Treatment: Other - Probiotic S. salivarius K12 powder containing prebiotics A and B
Treatment: Other - Probiotic S. salivarius M18 lozenges
Treatment: Other - Probiotic S. salivarius M18 lozenges containing prebiotic A
Treatment: Other - Probiotic S. salivarius M18 lozenges containing prebiotic B
Treatment: Other - 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


Treatment: Other: 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.

Treatment: Other: 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.

Treatment: Other: 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.

Treatment: Other: 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.

Treatment: Other: 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

Treatment: Other: 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

Treatment: Other: 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

Treatment: Other: 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

Treatment: Other: 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.

Treatment: Other: 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.

Treatment: Other: 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.

Treatment: Other: 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
Treatment: Other
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
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


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
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT05375383