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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05375396




Registration number
NCT05375396
Ethics application status
Date submitted
11/05/2022
Date registered
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
Treatment: Other - Streptococcus salivarius M18 lozenges
Treatment: Other - 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


Treatment: Other: 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.

Treatment: Other: 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
Treatment: Other
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
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
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data and information included in the Protocol and Clinical Study Report will be shared to other researchers and/or in publications in due course.

Supporting document/s available: Study protocol, Clinical study report (CSR)
When will data be available (start and end dates)?
Study report 3 months after the completion of the study
Available to whom?
Summary study report will be shared by Principal Investigator upon request if not published in public literature
Available for what types of analyses?
How or where can data be obtained?


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/NCT05375396