Clinical trial NCT06166979: Colonisation of Scalp by Topical Probiotic Micrococcus Luteus Q24
Official title: Assessment of Colonization and Scalp Quality Parameter Improvement by Topical Application of Probiotic Micrococcus Luteus Q24 in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbial Colonization
Lead sponsor: BLIS Technologies Limited
Sponsor class: INDUSTRY
First posted: 2023-12-12
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: This is a randomized double-blind baseline controlled pilot study with no crossover.
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 scalp 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 on the scalp 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, is 18 - 80 years of age.
2. Practice good general body and hair hygiene.

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.

Primary outcomes:
measure: Change in microbial composition following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days
timeFrame: 15 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 15 days
timeFrame: 15 days post intervention
measure: Change in Skin quality parameters following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days
timeFrame: 15 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 15 days
timeFrame: 15 days post intervention
measure: Change in microbial composition following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days
timeFrame: 29 days post intervention
measure: Change in Skin quality parameters following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days
timeFrame: 29 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 29 days
timeFrame: 29 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 29 days
timeFrame: 29 days post intervention
measure: Change in microbial composition post 7 days of last application of 1e8 cfu of Micrococcus luteus Q24 in serum
timeFrame: 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: 7 days post last intervention
measure: Change in Skin quality parameters post 7 days of last application of 1e8 cfu of Micrococcus luteus Q24 in serum
timeFrame: 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: 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: 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.
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.
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.