Clinical trial NCT06137209: Colonization of Skin by M. Luteus Q24 Probiotic
Official title: Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Serum in Healthy Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Microbial Colonization
Keywords: probiotics
Lead sponsor: BLIS Technologies Limited
Sponsor class: INDUSTRY
First posted: 2023-11-18
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 serum containing Micrococcus luteus Q24 at a low or higher dose of probiotic.

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

Group B: Probiotic Micrococcus luteus Q24 serum (dose:1e6 colony forming units per application of serum)
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 face from a serum format in healthy adults.

Detailed description: This is a randomized double-blind baseline 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 colonization 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 serum format.

Eligibility criteria: Inclusion criteria:

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

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.

Primary outcomes:
measure: Change in microbial composition following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
timeFrame: Time Frame: 11 days post intervention
measure: Change in skin quality parameters following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
timeFrame: Time Frame: 11 days post intervention
measure: Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
timeFrame: Time Frame: 11 days post intervention
measure: Change in skin quality parameters following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days
timeFrame: Time Frame: 11 days post intervention
measure: Change in microbial composition following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
timeFrame: Time Frame: 30 days post intervention
measure: Change in skin quality parameters following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
timeFrame: Time Frame: 30 days post intervention
measure: Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
timeFrame: Time Frame: 30 days post intervention
measure: Change in skin quality parameters following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days
timeFrame: Time Frame: 30 days post intervention
measure: Change in microbial composition post 7 days of last application of 1e7 cfu of Micrococcus luteus Q24 in serum.
timeFrame: Time Frame: 7 days post last intervention
measure: Change in skin quality parameters post 7 days of last application of 1e7 cfu of Micrococcus luteus Q24 in serum.
timeFrame: Time Frame: 7 days post last intervention
measure: Change in microbial composition post 7 days of last application of 1e6 cfu of Micrococcus luteus Q24 in serum.
timeFrame: Time Frame: 7 days post last intervention
measure: Change in skin quality parameters post 7 days of last application of 1e6 cfu of Micrococcus luteus Q24 in serum.
timeFrame: Time Frame: 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.