Microbial ColonizationNCT05750381
Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.
A study testing Micrococcus luteus Blis Q24 balm in people with Microbial Colonization, run by BLIS Technologies Limited at 1 site in New Zealand.
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 elbow and back of forearm in a topical balm format in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Micrococcus luteus Blis Q24 balm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- 24 Jan 2023to 12 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In general good health 18 - 80 years of age.
- Practice good general body hygiene
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site, 1 recruiting
- Recruiting
Blis Technologies Ltd
Dunedin, Otago, 9012
John D Hale, PhD, +6434740988, john.hale@blis.co.nz
Rohit Jain, PhD
About this study
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.
Read the 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.
- Conditions
- Microbial Colonization
- Being tested
- Micrococcus luteus Blis Q24 balm, Placebo balm
- Keywords
- probiotic
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micrococcus luteus Blis Q24 balmOther
Balm formulation containing probiotic bacteria Micrococcus luteus Q24 for topical applications.
Placebo balmOther
Placebo balm formulation for topical applications.
| Study group | Role | What they receive |
|---|---|---|
| Study Group A: Blis Q24 balm (Active) | Active comparator | Group A: Probiotic Micrococcus luteus Q24 balm (dose: 1e7 colony forming units per application) Receives: Other: Micrococcus luteus Blis Q24 balm |
| Study Group B: Placebo balm (without Blis Q24) | Placebo comparator | Group A: Placebo balm Receives: Other: Placebo balm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days post last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start24 Jan 2023
- Primary completion10 Mar 2023 (estimated)
- Study completion12 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BLIS Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750381
- Sponsor's protocol ID
- BLTCT2022/8
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and information in the protocol and the clinical study report will be shared to other researchers and/or in publications in due course.
Publications
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.
PubMed 26374122Bourdichon 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.
PubMed 22257932
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.
- ClinicalTrials.gov ID
- NCT05750381
- Acronym / sponsor ID
- BLTCT2022/8
- Conditions
- Microbial Colonization
- Keywords
- probiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BLIS Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 10 Mar 2023 (estimated)
- Study completion
- 12 Apr 2023 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Study Group A: Blis Q24 balm (Active) | Active comparator | Other: Micrococcus luteus Blis Q24 balmGroup A: Probiotic Micrococcus luteus Q24 balm (dose: 1e7 colony forming units per application) |
| Study Group B: Placebo balm (without Blis Q24) | Placebo comparator | Other: Placebo balmGroup A: Placebo balm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In general good health 18 - 80 years of age.
- Practice good general body hygiene
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micrococcus luteus Blis Q24 balmBalm formulation containing probiotic bacteria Micrococcus luteus Q24 for topical applications. | Other | Study Group A: Blis Q24 balm (Active) |
| Placebo balmPlacebo balm formulation for topical applications. | Other | Study Group B: Placebo balm (without Blis Q24) |
Primary outcome
Change in microbial composition on skin following application of Micrococcus luteus Q24 in balm from Day 0 (baseline) to 11 days
Time frame: 11 days post intervention
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
Time frame: 11 days post intervention
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.
Time frame: 7 days post last intervention
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
Time frame: 7 days post last intervention
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
Time frame: 11 days post last intervention
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
Time frame: 11 days post last intervention
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.
Time frame: 7 days post last intervention
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.
Time frame: 7 days post last intervention
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 26374122van 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.
- Background: PubMed 22257932Bourdichon 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.
- Individual participant dataSharing planned: Yes. Data and information in the protocol and the clinical study report will be shared to other researchers and/or in publications in due course.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micrococcus luteus Blis Q24 balm in people with Microbial Colonization, run by BLIS Technologies Limited at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbial composition on skin following application of Micrococcus luteus Q24 in balm from Day 0 (baseline) to 11 days (time frame: 11 days post intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05750381, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.