Clinical trial NCT05750381: Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.
Official title: Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbial Colonization
Keywords: probiotic
Lead sponsor: BLIS Technologies Limited
Sponsor class: INDUSTRY
First posted: 2023-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups applying balm containing Micrococcus luteus Q24 or placebo balm.

Group A: Probiotic Micrococcus luteus Q24 balm (dose:1e7 colony forming units per application of balm).

Group B: Placebo balm (dose:0 colony forming units per application of balm).
Primary purpose: BASIC_SCIENCE

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.

Detailed description: This is a randomized double-blind, placebo-controlled pilot study with no crossover for the assessment of any changes to the microbial make-up of the skin (The local skin microbiome), detection of colonisation by the probiotic bacterium (BLIS Q24) on the skin and to evaluate the changes in skin quality parameters following topical application of probiotic in a balm format.

Eligibility criteria: Inclusion Criteria:

* In general good health 18 - 80 years of age.
* Practice good general body hygiene

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.

Primary outcomes:
measure: Change in microbial composition on skin following application of Micrococcus luteus Q24 in balm from Day 0 (baseline) to 11 days
timeFrame: 11 days post intervention
measure: Change in microbial composition on skin following application of placebo balm from Day 0 (baseline) to 11 days
timeFrame: 11 days post intervention
measure: Change in microbial composition on skin post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days.
timeFrame: 7 days post last intervention
measure: Change in microbial composition on skin post 10 day application application of placebo balm from Day 11 (baseline) to 18 days
timeFrame: 7 days post last intervention
measure: Change in skin quality parameters following topical application Micrococcus luteus Q24 from Day 0 (baseline) to 11 days
timeFrame: 11 days post last intervention
measure: Change in skin quality parameters following topical application of placebo balm from Day 0 (baseline) to 11 days
timeFrame: 11 days post last intervention
measure: Change in skin quality parameters post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days.
timeFrame: 7 days post last intervention
measure: Change in skin quality parameters post 10 days application of placebo balm from Day 11 (baseline) to 18 days.
timeFrame: 7 days post last intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dunedin
country: New Zealand
facility: Blis Technologies Ltd
state: Otago
Study officials:
References:
citation: 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.
citation: 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.