Colonization of Skin by M. Luteus Q24 Probiotic

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 face from a serum format in healthy adults.

Detailed Description
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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.

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

Conditions
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Microbial Colonization

Intervention / Treatment
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* Other: Active Comparator: Study Group A: Blis Q24 Serum at higher dose
* Other: Active Comparator: Study Group B: Blis Q24 Serum at lower dose


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 (have a weakened immune system). 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 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)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active)<br>Group A: Probiotic Micrococcus luteus Q24 serum (dose: 1e7 colony forming units per application) | Other: Active Comparator: Study Group A: Blis Q24 Serum at higher dose<br>* Active Comparator: Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active)<br>|
| Active Comparator: Study Group B: Blis Q24 Serum at 1e6 cfu/ dose (Active)<br>Group B: Probiotic Micrococcus luteus Q24 serum (dose: 1e6 colony forming units per application) | Other: Active Comparator: Study Group B: Blis Q24 Serum at lower dose<br>* Active Comparator: Study Group B: Blis Q24 Serum at 1e6 cfu/ dose (Active)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbial composition following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days | Study will determine the change in microbial composition following the application of 1e7 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 11 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. | Time Frame: 11 days post intervention | 
| Change in skin quality parameters following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days | Study will determine the change in skin quality parameters following the application of 1e7 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 11 days across one site with a level of significance of p<0.05. Overall skin quality data based on percentage of population will also be analyzed using appropriate statistical analysis software. Analysis will be performed using a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles. | Time Frame: 11 days post intervention | 
| Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 11 days | Study will determine the change in microbial composition following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 11 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. | Time Frame: 11 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 11 days | Study will determine the change in skin quality parameters following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 11 days across one site with a level of significance of p<0.05. Overall skin quality data based on percentage of population will also be analyzed using appropriate statistical analysis software. Analysis will be performed using a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles. | Time Frame: 11 days post intervention | 
| Change in microbial composition following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days | Study will determine the change in microbial composition following the application of a serum containing 1e7 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 30 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. | Time Frame: 30 days post intervention | 
| Change in skin quality parameters following application of 1e7 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days | Study will determine the change in skin quality parameters following the application of 1e7 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 30 days across one site with a level of significance of p<0.05. Overall skin quality data based on percentage of population will also be analyzed using appropriate statistical analysis software. Analysis will be performed using a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles. | Time Frame: 30 days post intervention | 
| Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 30 days | Study will determine the change in microbial composition following the application of a serum containing 1e6 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 30 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. | Time Frame: 30 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 30 days | Study will determine the change in skin quality parameters following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 30 days across one site with a level of significance of p<0.05. Overall skin quality data based on percentage of population will also be analyzed using appropriate statistical analysis software. Analysis will be performed using a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles. | Time Frame: 30 days post intervention | 
| Change in microbial composition post 7 days of last application of 1e7 cfu of Micrococcus luteus Q24 in serum. | Study will determine the change in microbial composition following the application of a serum containing 1e7 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data at Day 37 (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. | Time Frame: 7 days post last intervention | 
| Change in skin quality parameters post 7 days of last application of 1e7 cfu of Micrococcus luteus Q24 in serum. | Study will determine the change in skin quality parameters following the application of a serum containing 1e7 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data at Day 37 (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 a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles. | Time Frame: 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 a serum containing 1e6 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data at Day 37 (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. | Time Frame: 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 skin quality parameters following the application of a serum containing 1e6 cfu per dose of Micrococcus luteus Q24 serum at one body site (face). The statistical analysis will be carried out to compare the participants skin swab data at Day 37 (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 a portable handheld skin analyzer device that measures key cosmetic parameters such as hydration, pores, spots and wrinkles. | Time Frame: 7 days post last intervention | 

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