Colonization of Skin by M. Luteus Q24 Probiotic

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Microbial Colonization
• Intervention / Treatment: Other: Active Comparator: Study Group A: Blis Q24 Serum at higher dose; Other: Active Comparator: Study Group B: Blis Q24 Serum at lower dose

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 and to evaluate the changes in skin quality parameters following topical application of probiotic in a serum format.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Otago
    • Dunedin, Otago, New Zealand, 9012
      • Blis Technologies Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. In general good health 18 - 80 years of age.
2. Practice good general body hygiene.

Exclusion criteria:

1. Have a history of autoimmune disease or are immunocompromised (have a weakened immune system).
2. Are on concurrent antibiotic therapy or regular antibiotic use within the last 1 week.
3. People with allergies or sensitivity to dairy.
4. People with an open wound on the Blis Q24 application sites.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active); 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; Active Comparator: Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active)
Active Comparator: Study Group B: Blis Q24 Serum at 1e6 cfu/ dose (Active); 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; Active Comparator: Study Group B: Blis Q24 Serum at 1e6 cfu/ dose (Active)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BLIS Technologies Limited

Publications and helpful links

General Publications

• 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. Erratum In: Int J Food Microbiol. 2012 Jun 1;156(3):301.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): November 22, 2023
• Study Completion (Estimated): March 15, 2024

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: probiotics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: BLTCT2022/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data and information in the protocol and the clinical study report will be shared to other researchers and/or in publications in due course.
• IPD Sharing Time Frame: Study report 3 months after completion of the study.
• IPD Sharing Access Criteria: Summary study report will be shared by the Principal Investigator upon request if not published in public literature.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No