Colonisation of Scalp by Topical Probiotic Micrococcus Luteus Q24

Assessment of Colonization and Scalp Quality Parameter Improvement by Topical Application of Probiotic Micrococcus Luteus Q24 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 scalp from a serum format in healthy adults.

Study Overview

• Status: Completed
• 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 on the scalp 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, is 18 - 80 years of age.
2. Practice good general body and hair hygiene.

Exclusion Criteria:

1. Have a history of autoimmune disease or are immunocompromised (have a weakened immune system).
2. Free from any scalp disease, active cut, or open wound
3. On hair loss treatment at least 2 months prior to sampling.
4. Have used anti-dandruff shampoos on the scalp and hair for at least 1 week prior to the trial.
5. On concurrent antibiotic or antifungal therapy or regular antibiotic or antifungal. use within the last 1 week.
6. People with allergies or sensitivity to dairy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Group A: Probiotic Micrococcus luteus Q24 serum (high dose); Group A: Probiotic Micrococcus luteus Q24 serum (dose: 1e8 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 1e8 cfu/ dose (Active)
Active Comparator: Study Group B: Probiotic Micrococcus luteus Q24 serum (low dose); Group : 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 A: 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 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days	Study will determine the change in microbial composition following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 15 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.	15 days post intervention
Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days	Study will determine the change in microbial composition following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 15 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.	15 days post intervention
Change in Skin quality parameters following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days	Study will determine the change in skin quality parameters following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 15 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.	15 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 15 days	Study will determine the change in skin quality parameters following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 15 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.	15 days post intervention
Change in microbial composition following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days	Study will determine the change in microbial composition following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 29 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.	29 days post intervention
Change in Skin quality parameters following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days	Study will determine the change in skin quality parameters following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 29 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.	29 days post intervention
Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days	Study will determine the change in microbial composition following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 29 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.	29 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 29 days	Study will determine the change in skin quality parameters following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data from baseline to 29 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.	29 days post intervention
Change in microbial composition post 7 days of last application of 1e8 cfu of Micrococcus luteus Q24 in serum	Study will determine the change in microbial composition following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data at Day 36(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.	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 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data at Day 36(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.	7 days post last intervention
Change in Skin quality parameters post 7 days of last application of 1e8 cfu of Micrococcus luteus Q24 in serum	Study will determine the change in microbial composition following the application of 1e8 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data at Day 36(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.	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 microbial composition following the application of 1e6 cfu per dose serum containing Micrococcus luteus Q24 serum to the scalp. The statistical analysis will be carried out to compare the participants skin swab data at Day 36(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.	7 days post last intervention

Collaborators and Investigators

• Sponsor: BLIS Technologies Limited

Publications and helpful links

General Publications

• Oh J, Byrd AL, Deming C, Conlan S; NISC Comparative Sequencing Program; Kong HH, Segre JA. Biogeography and individuality shape function in the human skin metagenome. Nature. 2014 Oct 2;514(7520):59-64. doi: 10.1038/nature13786.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): February 25, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: BLTCT2023/1

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
• product manufactured in and exported from the U.S.: No