Back to resultsAssessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.
Primary Purpose
Microbial Colonization
Status
Recruiting
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Micrococcus luteus Blis Q24 balm
Placebo balm
Sponsored by
About this trial
This is an interventional basic science trial for Microbial Colonization focused on measuring probiotic
Eligibility Criteria
Inclusion Criteria: In general good health 18 - 80 years of age. Practice good general body hygiene Exclusion Criteria: 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.
Sites / Locations
- Blis Technologies LtdRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Study Group A: Blis Q24 balm (Active)
Study Group B: Placebo balm (without Blis Q24)
Arm Description
Group A: Probiotic Micrococcus luteus Q24 balm (dose: 1e7 colony forming units per application)
Group A: Placebo balm
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05750381
First Posted
February 20, 2023
Last Updated
February 20, 2023
Sponsor
BLIS Technologies Limited
1. Study Identification
Unique Protocol Identification Number
NCT05750381
Brief Title
Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.
Official Title
Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
March 10, 2023 (Anticipated)
Study Completion Date
April 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BLIS Technologies Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a randomized double-blind, placebo-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 colonisation 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 balm format.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
Keywords
probiotic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group A: Blis Q24 balm (Active)
Arm Type
Active Comparator
Arm Description
Group A: Probiotic Micrococcus luteus Q24 balm (dose: 1e7 colony forming units per application)
Arm Title
Study Group B: Placebo balm (without Blis Q24)
Arm Type
Placebo Comparator
Arm Description
Group A: Placebo balm
Intervention Type
Other
Intervention Name(s)
Micrococcus luteus Blis Q24 balm
Intervention Description
Balm formulation containing probiotic bacteria Micrococcus luteus Q24 for topical applications.
Intervention Type
Other
Intervention Name(s)
Placebo balm
Intervention Description
Placebo balm formulation for topical applications.
Primary Outcome Measure Information:
Title
Change in microbial composition on skin following application of Micrococcus luteus Q24 in balm from Day 0 (baseline) to 11 days
Description
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.
Time Frame
11 days post intervention
Title
Change in microbial composition on skin following application of placebo balm from Day 0 (baseline) to 11 days
Description
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.
Time Frame
11 days post intervention
Title
Change in microbial composition on skin post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days.
Description
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.
Time Frame
7 days post last intervention
Title
Change in microbial composition on skin post 10 day application application of placebo balm from Day 11 (baseline) to 18 days
Description
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.
Time Frame
7 days post last intervention
Title
Change in skin quality parameters following topical application Micrococcus luteus Q24 from Day 0 (baseline) to 11 days
Description
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.
Time Frame
11 days post last intervention
Title
Change in skin quality parameters following topical application of placebo balm from Day 0 (baseline) to 11 days
Description
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.
Time Frame
11 days post last intervention
Title
Change in skin quality parameters post 10 days application of Micrococcus luteus Q24 in balm from Day 11 (baseline) to 18 days.
Description
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.
Time Frame
7 days post last intervention
Title
Change in skin quality parameters post 10 days application of placebo balm from Day 11 (baseline) to 18 days.
Description
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.
Time Frame
7 days post last intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
In general good health 18 - 80 years of age.
Practice good general body hygiene
Exclusion Criteria:
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.
Facility Information:
Facility Name
Blis Technologies Ltd
City
Dunedin
State/Province
Otago
ZIP/Postal Code
9012
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John D Hale, PhD
Phone
+6434740988
Email
john.hale@blis.co.nz
First Name & Middle Initial & Last Name & Degree
Rohit Jain, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
26374122
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.
Results Reference
background
PubMed Identifier
22257932
Citation
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.
Results Reference
background
Learn more about this trial
Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.
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