Colonization of Skin by M. Luteus Q24 Probiotic

NCT06137209 | Unknown

• 1 other identifier: BLTCT2022/10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microbial Colonization

Keywords

probiotics

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active)

ACTIVE COMPARATOR

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

Study Group B: Blis Q24 Serum at 1e6 cfu/ dose (Active)

ACTIVE COMPARATOR

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

Interventions

Active Comparator: Study Group A: Blis Q24 Serum at higher dose OTHER

Active Comparator: Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active)

Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active)

Active Comparator: Study Group B: Blis Q24 Serum at lower dose OTHER

Active Comparator: Study Group B: Blis Q24 Serum at 1e6 cfu/ dose (Active)

Study Group B: Blis Q24 Serum at 1e6 cfu/ dose (Active)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BLIS Technologies Limited: lead

Study Sites (1)

Blis Technologies Ltd

Dunedin, Otago, 9012, New Zealand

Location

Related Publications (2)

• 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.

  PMID: 26374122 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.

  PMID: 22257932 BACKGROUND

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A Staff member will be assigned to distribute blinded samples. The investigator will not be aware of the dose groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 18, 2023
• Study Start: October 2, 2023
• Primary Completion: November 22, 2023
• Study Completion: March 15, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Study report 3 months after completion of the study.
• Access Criteria: Summary study report will be shared by the Principal Investigator upon request if not published in public literature.

Locations

NZ (1)