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

NCT05750381 | Unknown

• 1 other identifier: BLTCT2022/8
• 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 elbow and back of forearm in a topical balm format in healthy adults.

Conditions

Microbial Colonization

Keywords

probiotic

Outcome Measures

Primary Outcomes (8)

• Change in microbial composition on skin following application of Micrococcus luteus Q24 in balm from Day 0 (baseline) to 11 days

  Study will determine the change in microbial composition following the application of a balm containing Micrococcus luteus Q24 balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 11 days across two different sites 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.

  11 days post intervention

• Change in microbial composition on skin following application of placebo balm from Day 0 (baseline) to 11 days

  Study will determine the change in microbial composition following the application of a placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from baseline to 11 days across two different sites 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.

  11 days post intervention

• Change in microbial composition on skin post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days.

  Study will determine the change in microbial composition post 10 days application of Micrococcus luteus Q24 at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from Day 11 to 18 days across two different sites 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.

  7 days post last intervention

• Change in microbial composition on skin post 10 day application application of placebo balm from Day 11 (baseline) to 18 days

  Study will determine the change in microbial composition following the application of a placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin swab data from Day 11 to 18 days across two different sites 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.

  7 days post last intervention

• Change in skin quality parameters following topical application Micrococcus luteus Q24 from Day 0 (baseline) to 11 days

  Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of Micrococcus luteus Q24 balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 11 days across two different sites with a level of significance of p\<0.05.

  11 days post last intervention

• Change in skin quality parameters following topical application of placebo balm from Day 0 (baseline) to 11 days

  Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from baseline to 11 days across two different sites with a level of significance of p\<0.05.

  11 days post last intervention

• Change in skin quality parameters post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days.

  Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of Micrococcus luteus Q24 balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from Day 11 to Day 18 across two different sites with a level of significance of p\<0.05.

  7 days post last intervention

• Change in skin quality parameters post 10 days application of placebo balm from Day 11 (baseline) to 18 days.

  Study will determine the change in skin quality parameters using a skin quality analyzer following topical application of placebo balm at two body sites (elbow and back of hand). The statistical analysis will be carried out to compare the participants skin quality data from Day 11 to Day 18 across two different sites with a level of significance of p\<0.05.

  7 days post last intervention

Study Arms (2)

Study Group A: Blis Q24 balm (Active)

ACTIVE COMPARATOR

Group A: Probiotic Micrococcus luteus Q24 balm (dose: 1e7 colony forming units per application)

Other: Micrococcus luteus Blis Q24 balm

Study Group B: Placebo balm (without Blis Q24)

PLACEBO COMPARATOR

Group A: Placebo balm

Other: Placebo balm

Interventions

Micrococcus luteus Blis Q24 balm OTHER

Balm formulation containing probiotic bacteria Micrococcus luteus Q24 for topical applications.

Study Group A: Blis Q24 balm (Active)

Placebo balm OTHER

Placebo balm formulation for topical applications.

Study Group B: Placebo balm (without Blis Q24)

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.
• 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

RECRUITING

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: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A Staff member, not part of the study group will be assigned to distribute blinded samples. The investigator will not be are 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 balm containing Micrococcus luteus Q24 or placebo balm. Group A: Probiotic Micrococcus luteus Q24 balm (dose:1e7 colony forming units per application of balm). Group B: Placebo balm (dose:0 colony forming units per application of balm).

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 1, 2023
• Study Start: January 24, 2023
• Primary Completion: March 10, 2023
• Study Completion: April 12, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

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)