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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group A: Probiotic Micrococcus luteus Q24 serum (high dose) | Active Comparator | Group A: Probiotic Micrococcus luteus Q24 serum (dose: 1e8 colony forming units per application) |
|
| Study Group B: Probiotic Micrococcus luteus Q24 serum (low dose) | Active Comparator | Group : Probiotic Micrococcus luteus Q24 serum (dose: 1e6 colony forming units per application) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator: Study Group A: Blis Q24 Serum at higher dose | Other | Active Comparator: Study Group A: Blis Q24 Serum at 1e8 cfu/ dose (Active) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbial composition following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days | Study will determine the change in microbial composition following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 15 days across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. | 15 days post intervention |
| Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days | Study will determine the change in microbial composition following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 15 days across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. | 15 days post intervention |
| Change in Skin quality parameters following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days | Study will determine the change in skin quality parameters following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 15 days across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blis Technologies Ltd | Dunedin | Otago | 9012 | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25279917 | Background | 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. | |
| 22257932 | Background | 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. |
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Data and information in the protocol and the clinical study report will be shared to other researchers and/or in publications in due course.
Study report 3 months after completion of the study.
Summary study report will be shared by the Principal Investigator upon request if not published in public literature.
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a randomized double-blind baseline controlled pilot study with no crossover.
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Both participants and investigator are blinded.
| Active Comparator: Study Group B: Blis Q24 Serum at lower dose | Other | Active Comparator: Study Group A: Blis Q24 Serum at 1e6 cfu/ dose (Active) |
|
| 15 days post intervention |
| Change in Skin quality parameters following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days | Study will determine the change in skin quality parameters following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 15 days across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. | 15 days post intervention |
| Change in microbial composition following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days | Study will determine the change in microbial composition following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 29 days across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. | 29 days post intervention |
| Change in Skin quality parameters following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days | Study will determine the change in skin quality parameters following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 29 days across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. | 29 days post intervention |
| Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days | Study will determine the change in microbial composition following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 29 days across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. | 29 days post intervention |
| Change in Skin quality parameters following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days | Study will determine the change in skin quality parameters following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 29 days across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. | 29 days post intervention |
| Change in microbial composition post 7 days of last application of 1e8 cfu of Micrococcus luteus Q24 in serum | Study will determine the change in microbial composition following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data at Day 36(i.e. post 7 days from last application) across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. | 7 days post last intervention |
| Change in microbial composition post 7 days of last application of 1e6 cfu of Micrococcus luteus Q24 in serum | Study will determine the change in microbial composition following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data at Day 36(i.e. post 7 days from last application) across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. | 7 days post last intervention |
| Change in Skin quality parameters post 7 days of last application of 1e8 cfu of Micrococcus luteus Q24 in serum | Study will determine the change in microbial composition following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data at Day 36(i.e. post 7 days from last application) across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. | 7 days post last intervention |
| Change in Skin quality parameters post 7 days of last application of 1e6 cfu of Micrococcus luteus Q24 in serum | Study will determine the change in microbial composition following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data at Day 36(i.e. post 7 days from last application) across one site with a level of significance of p<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software. Analysis will be performed using bacterial genome sequence analysis of the skin swab samples collected. | 7 days post last intervention |
| 26374122 | Background | 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. |