Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.

Conditions
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Microbial Colonization

Intervention / Treatment
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* Other: Micrococcus luteus Blis Q24 balm
* Other: Placebo balm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group A: Blis Q24 balm (Active)<br>Group A: Probiotic Micrococcus luteus Q24 balm (dose: 1e7 colony forming units per application) | Other: Micrococcus luteus Blis Q24 balm<br>* Balm formulation containing probiotic bacteria Micrococcus luteus Q24 for topical applications.<br>|
| Placebo Comparator: Study Group B: Placebo balm (without Blis Q24)<br>Group A: Placebo balm | Other: Placebo balm<br>* Placebo balm formulation for topical applications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic