Colonisation of Scalp by Topical Probiotic Micrococcus Luteus Q24

Microbial Colonization Clinical Trial

Official title:

Assessment of Colonization and Scalp Quality Parameter Improvement by Topical Application of Probiotic Micrococcus Luteus Q24 in Healthy Adults.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06166979
• Other study ID #: BLTCT2023/1
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2023
• Source: BLIS Technologies Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 scalp from a serum format in healthy adults.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 31, 2024
• Est. primary completion date: February 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

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

Locations

Country	Name	City	State
New Zealand	Blis Technologies Ltd	Dunedin	Otago

Sponsors (1)

Lead Sponsor	Collaborator
BLIS Technologies Limited

Country where clinical trial is conducted

New Zealand, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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