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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06137209




Registration number
NCT06137209
Ethics application status
Date submitted
5/11/2023
Date registered
18/11/2023

Titles & IDs
Public title
Colonization of Skin by M. Luteus Q24 Probiotic
Scientific title
Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Serum in Healthy Adults
Secondary ID [1] 0 0
BLTCT2022/10
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 - Active Comparator: Study Group A: Blis Q24 Serum at higher dose
Other interventions - Active Comparator: Study Group B: Blis Q24 Serum at lower dose

Active comparator: Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active) - Group A: Probiotic Micrococcus luteus Q24 serum (dose: 1e7 colony forming units per application)

Active comparator: Study Group B: Blis Q24 Serum at 1e6 cfu/ dose (Active) - Group B: Probiotic Micrococcus luteus Q24 serum (dose: 1e6 colony forming units per application)


Other interventions: Active Comparator: Study Group A: Blis Q24 Serum at higher dose
Active Comparator: Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active)

Other interventions: Active Comparator: Study Group B: Blis Q24 Serum at lower dose
Active Comparator: Study Group B: Blis Q24 Serum at 1e6 cfu/ dose (Active)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in microbial composition following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
Timepoint [1] 0 0
Time Frame: 11 days post intervention
Primary outcome [2] 0 0
Change in skin quality parameters following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
Timepoint [2] 0 0
Time Frame: 11 days post intervention
Primary outcome [3] 0 0
Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
Timepoint [3] 0 0
Time Frame: 11 days post intervention
Primary outcome [4] 0 0
Change in skin quality parameters following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
Timepoint [4] 0 0
Time Frame: 11 days post intervention
Primary outcome [5] 0 0
Change in microbial composition following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
Timepoint [5] 0 0
Time Frame: 30 days post intervention
Primary outcome [6] 0 0
Change in skin quality parameters following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
Timepoint [6] 0 0
Time Frame: 30 days post intervention
Primary outcome [7] 0 0
Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
Timepoint [7] 0 0
Time Frame: 30 days post intervention
Primary outcome [8] 0 0
Change in skin quality parameters following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
Timepoint [8] 0 0
Time Frame: 30 days post intervention
Primary outcome [9] 0 0
Change in microbial composition post 7 days of last application of 1e7 cfu of Micrococcus luteus Q24 in serum.
Timepoint [9] 0 0
Time Frame: 7 days post last intervention
Primary outcome [10] 0 0
Change in skin quality parameters post 7 days of last application of 1e7 cfu of Micrococcus luteus Q24 in serum.
Timepoint [10] 0 0
Time Frame: 7 days post last intervention
Primary outcome [11] 0 0
Change in microbial composition post 7 days of last application of 1e6 cfu of Micrococcus luteus Q24 in serum.
Timepoint [11] 0 0
Time Frame: 7 days post last intervention
Primary outcome [12] 0 0
Change in skin quality parameters post 7 days of last application of 1e6 cfu of Micrococcus luteus Q24 in serum.
Timepoint [12] 0 0
Time Frame: 7 days post last intervention

Eligibility
Key inclusion criteria
Inclusion criteria:

1. In general good health 18 - 80 years of age.
2. Practice good general body 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 (have a weakened immune system).
2. Are on concurrent antibiotic therapy or regular antibiotic use within the last 1 week.
3. People with allergies or sensitivity to dairy.
4. People with an open wound on the Blis Q24 application sites.

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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/03/2024
Actual
Sample size
Target
Accrual to date
Final
20
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
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

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 in the protocol and the 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 completion of the study.
Available to whom?
Summary study report will be shared by the 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/NCT06137209