Trial Review

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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/NCT05750381




Registration number
NCT05750381
Ethics application status
Date submitted
20/02/2023
Date registered
1/03/2023
Date last updated
1/03/2023

Titles & IDs
Public title
Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.
Scientific title
Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.
Secondary ID [1] 0 0
BLTCT2022/8
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 - Micrococcus luteus Blis Q24 balm
Other interventions - Placebo balm

Active Comparator: Study Group A: Blis Q24 balm (Active) - Group A: Probiotic Micrococcus luteus Q24 balm (dose: 1e7 colony forming units per application)

Placebo Comparator: Study Group B: Placebo balm (without Blis Q24) - Group A: Placebo balm


Other interventions: Micrococcus luteus Blis Q24 balm
Balm formulation containing probiotic bacteria Micrococcus luteus Q24 for topical applications.

Other interventions: Placebo balm
Placebo balm formulation for topical applications.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in microbial composition on skin following application of Micrococcus luteus Q24 in balm from Day 0 (baseline) to 11 days
Timepoint [1] 0 0
11 days post intervention
Primary outcome [2] 0 0
Change in microbial composition on skin following application of placebo balm from Day 0 (baseline) to 11 days
Timepoint [2] 0 0
11 days post intervention
Primary outcome [3] 0 0
Change in microbial composition on skin post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days.
Timepoint [3] 0 0
7 days post last intervention
Primary outcome [4] 0 0
Change in microbial composition on skin post 10 day application application of placebo balm from Day 11 (baseline) to 18 days
Timepoint [4] 0 0
7 days post last intervention
Primary outcome [5] 0 0
Change in skin quality parameters following topical application Micrococcus luteus Q24 from Day 0 (baseline) to 11 days
Timepoint [5] 0 0
11 days post last intervention
Primary outcome [6] 0 0
Change in skin quality parameters following topical application of placebo balm from Day 0 (baseline) to 11 days
Timepoint [6] 0 0
11 days post last intervention
Primary outcome [7] 0 0
Change in skin quality parameters post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days.
Timepoint [7] 0 0
7 days post last intervention
Primary outcome [8] 0 0
Change in skin quality parameters post 10 days application of placebo balm from Day 11 (baseline) to 18 days.
Timepoint [8] 0 0
7 days post last intervention

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

- 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
- Have a history of autoimmune disease or are immunocompromised.

- Are on concurrent antibiotic therapy or regular antibiotic use within the last 1 week.

- People with allergies or sensitivity to dairy.

- People with an open wound on the Blis Q24 application sites.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/04/2023
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
elbow and back of forearm in a topical balm format in healthy adults.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05750381
Trial related presentations / publications
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.
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.
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/NCT05750381