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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 elbow and back of forearm in a topical balm format in healthy adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group A: Blis Q24 balm (Active) | Active Comparator | Group A: Probiotic Micrococcus luteus Q24 balm (dose: 1e7 colony forming units per application) |
|
| Study Group B: Placebo balm (without Blis Q24) | Placebo Comparator | Group A: Placebo balm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micrococcus luteus Blis Q24 balm | Other | Balm formulation containing probiotic bacteria Micrococcus luteus Q24 for topical applications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbial composition on skin following application of Micrococcus luteus Q24 in balm from Day 0 (baseline) to 11 days | Study will determine the change in microbial composition following the application of a balm containing Micrococcus luteus Q24 balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 11 days across two different sites 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. | 11 days post intervention |
| Change in microbial composition on skin following application of placebo balm from Day 0 (baseline) to 11 days | Study will determine the change in microbial composition following the application of a placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 11 days across two different sites 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. | 11 days post intervention |
| Change in microbial composition on skin post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days. | Study will determine the change in microbial composition post 10 days application of Micrococcus luteus Q24 at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from Day 11 to 18 days across two different sites 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. | 7 days post last intervention |
| Change in microbial composition on skin post 10 day application application of placebo balm from Day 11 (baseline) to 18 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blis Technologies Ltd | Recruiting | Dunedin | Otago | 9012 | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 22257932 | Background |
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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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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).
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A Staff member, not part of the study group will be assigned to distribute blinded samples. The investigator will not be are of the dose groups.
| Placebo balm | Other | Placebo balm formulation for topical applications. |
|
Study will determine the change in microbial composition following the application of a placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from Day 11 to 18 days across two different sites 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. |
| 7 days post last intervention |
| Change in skin quality parameters following topical application Micrococcus luteus Q24 from Day 0 (baseline) to 11 days | Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of Micrococcus luteus Q24 balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 11 days across two different sites with a level of significance of p<0.05. | 11 days post last intervention |
| Change in skin quality parameters following topical application of placebo balm from Day 0 (baseline) to 11 days | Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 11 days across two different sites with a level of significance of p<0.05. | 11 days post last intervention |
| Change in skin quality parameters post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days. | Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of Micrococcus luteus Q24 balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from Day 11 to Day 18 across two different sites with a level of significance of p<0.05. | 7 days post last intervention |
| Change in skin quality parameters post 10 days application of placebo balm from Day 11 (baseline) to 18 days. | Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from Day 11 to Day 18 across two different sites with a level of significance of p<0.05. | 7 days post last intervention |
| 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. |