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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/NCT06166979




Registration number
NCT06166979
Ethics application status
Date submitted
4/12/2023
Date registered
12/12/2023
Date last updated
12/12/2023

Titles & IDs
Public title
Colonisation of Scalp by Topical Probiotic Micrococcus Luteus Q24
Scientific title
Assessment of Colonization and Scalp Quality Parameter Improvement by Topical Application of Probiotic Micrococcus Luteus Q24 in Healthy Adults.
Secondary ID [1] 0 0
BLTCT2023/1
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: Probiotic Micrococcus luteus Q24 serum (high dose) - Group A: Probiotic Micrococcus luteus Q24 serum (dose: 1e8 colony forming units per application)

Active Comparator: Study Group B: Probiotic Micrococcus luteus Q24 serum (low dose) - Group : 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 1e8 cfu/ dose (Active)

Other interventions: Active Comparator: Study Group B: Blis Q24 Serum at lower dose
Active Comparator: Study Group A: 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 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days
Timepoint [1] 0 0
15 days post intervention
Primary outcome [2] 0 0
Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days
Timepoint [2] 0 0
15 days post intervention
Primary outcome [3] 0 0
Change in Skin quality parameters following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days
Timepoint [3] 0 0
15 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 15 days
Timepoint [4] 0 0
15 days post intervention
Primary outcome [5] 0 0
Change in microbial composition following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days
Timepoint [5] 0 0
29 days post intervention
Primary outcome [6] 0 0
Change in Skin quality parameters following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days
Timepoint [6] 0 0
29 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 29 days
Timepoint [7] 0 0
29 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 29 days
Timepoint [8] 0 0
29 days post intervention
Primary outcome [9] 0 0
Change in microbial composition post 7 days of last application of 1e8 cfu of Micrococcus luteus Q24 in serum
Timepoint [9] 0 0
7 days post last intervention
Primary outcome [10] 0 0
Change in microbial composition post 7 days of last application of 1e6 cfu of Micrococcus luteus Q24 in serum
Timepoint [10] 0 0
7 days post last intervention
Primary outcome [11] 0 0
Change in Skin quality parameters post 7 days of last application of 1e8 cfu of Micrococcus luteus Q24 in serum
Timepoint [11] 0 0
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
7 days post last intervention

Eligibility
Key inclusion criteria
1. In general, good health, is 18 - 80 years of age.

2. Practice good general body and hair 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 (have a weakened immune
system).

2. Free from any scalp disease, active cut, or open wound

3. On hair loss treatment at least 2 months prior to sampling.

4. Have used anti-dandruff shampoos on the scalp and hair for at least 1 week prior to
the trial.

5. On concurrent antibiotic or antifungal therapy or regular antibiotic or antifungal.
use within the last 1 week.

6. People with allergies or sensitivity to 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 analysing the results/data
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
15/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2024
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 purpose of this study is to evaluate the skin quality improvement and colonization
efficacy following the application of probiotic Micrococcus luteus Q24 (BLIS Q24) to the
scalp from a serum format in healthy adults.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06166979
Trial related presentations / publications
Oh J, Byrd AL, Deming C, Conlan S; NISC Comparative Sequencing Program; Kong HH, Segre JA. Biogeography and individuality shape function in the human skin metagenome. Nature. 2014 Oct 2;514(7520):59-64. doi: 10.1038/nature13786.
Bourdichon F, Casaregola S, Farrokh C, Frisvad JC, Gerds ML, Hammes WP, Harnett J, Huys G, Laulund S, Ouwehand A, Powell IB, Prajapati JB, Seto Y, Ter Schure E, Van Boven A, Vankerckhoven V, Zgoda A, Tuijtelaars S, Hansen EB. Food fermentations: microorganisms with technological beneficial use. Int J Food Microbiol. 2012 Mar 15;154(3):87-97. doi: 10.1016/j.ijfoodmicro.2011.12.030. Epub 2011 Dec 31. Erratum In: Int J Food Microbiol. 2012 Jun 1;156(3):301.
van Rensburg JJ, Lin H, Gao X, Toh E, Fortney KR, Ellinger S, Zwickl B, Janowicz DM, Katz BP, Nelson DE, Dong Q, Spinola SM. The Human Skin Microbiome Associates with the Outcome of and Is Influenced by Bacterial Infection. mBio. 2015 Sep 15;6(5):e01315-15. doi: 10.1128/mBio.01315-15.
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/NCT06166979