Microbial ColonizationNCT06166979

Colonisation of Scalp by Topical Probiotic Micrococcus Luteus Q24

A study testing Active Comparator: Study Group A: Blis Q24 Serum at higher dose and Active Comparator: Study Group B: Blis Q24 Serum at lower dose in people with Microbial Colonization, run by BLIS Technologies Limited at 1 site in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. 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?: Active Comparator: Study Group A: Blis Q24 Serum at higher dose and Active Comparator: Study Group B: Blis Q24 Serum at lower dose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteNew Zealand
Study dates: 15 Jan 2024to 31 Jul 2024
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, is 18 - 80 years of age.
Practice good general body and hair hygiene.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

Blis Technologies Ltd
Dunedin, Otago, 9012

Other trials in New Zealand

About this study

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

Read the 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.

Conditions: Microbial Colonization
Being tested: Active Comparator: Study Group A: Blis Q24 Serum at higher dose, Active Comparator: Study Group B: Blis Q24 Serum at lower dose
Medical subject headings: Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active Comparator: Study Group A: Blis Q24 Serum at higher doseOther
Active Comparator: Study Group A: Blis Q24 Serum at 1e8 cfu/ dose (Active)
Active Comparator: Study Group B: Blis Q24 Serum at lower doseOther
Active Comparator: Study Group A: Blis Q24 Serum at 1e6 cfu/ dose (Active)

Study groups in NCT06166979
Study group	Role	What they receive
Study Group A: Probiotic Micrococcus luteus Q24 serum (high dose)	Active comparator	Group A: Probiotic Micrococcus luteus Q24 serum (dose: 1e8 colony forming units per application) Receives: Other: Active Comparator: Study Group A: Blis Q24 Serum at higher dose
Study Group B: Probiotic Micrococcus luteus Q24 serum (low dose)	Active comparator	Group : Probiotic Micrococcus luteus Q24 serum (dose: 1e6 colony forming units per application) Receives: Other: Active Comparator: Study Group B: Blis Q24 Serum at lower dose

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.

15 Jan 202431 Jul 2024

First posted12 Dec 2023
Study start15 Jan 2024
Primary completion25 Feb 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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: This is a randomized double-blind baseline controlled pilot study with no crossover.
Masking: Single blind
Who is masked: Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06166979
Sponsor's protocol ID: BLTCT2023/1
Status last verified: May 2025
First submitted: 4 Dec 2023
Last updated: 18 May 2025
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

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.
PubMed 25279917
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.
PubMed 22257932
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 26374122

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Colonization and Scalp Quality Parameter Improvement by Topical Application of Probiotic Micrococcus Luteus Q24 in Healthy Adults.
ClinicalTrials.gov ID: NCT06166979
Acronym / sponsor ID: BLTCT2023/1
Conditions: Microbial Colonization
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: BLIS Technologies LimitedIndustry (pharma, biotech, devices)
Study start: 15 Jan 2024 (actual)
Primary completion: 25 Feb 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 12 Dec 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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: This is a randomized double-blind baseline controlled pilot study with no crossover.

Arm	Type	Receives
Study Group A: Probiotic Micrococcus luteus Q24 serum (high dose)	Active comparator	Other: Active Comparator: Study Group A: Blis Q24 Serum at higher doseGroup A: Probiotic Micrococcus luteus Q24 serum (dose: 1e8 colony forming units per application)
Study Group B: Probiotic Micrococcus luteus Q24 serum (low dose)	Active comparator	Other: Active Comparator: Study Group B: Blis Q24 Serum at lower doseGroup : Probiotic Micrococcus luteus Q24 serum (dose: 1e6 colony forming units per application)

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, is 18 - 80 years of age.
Practice good general body and hair hygiene.

Key exclusion criteria (6 listed)

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

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
Active Comparator: Study Group A: Blis Q24 Serum at higher doseActive Comparator: Study Group A: Blis Q24 Serum at 1e8 cfu/ dose (Active)	Other	Study Group A: Probiotic Micrococcus luteus Q24 serum (high dose)
Active Comparator: Study Group B: Blis Q24 Serum at lower doseActive Comparator: Study Group A: Blis Q24 Serum at 1e6 cfu/ dose (Active)	Other	Study Group B: Probiotic Micrococcus luteus Q24 serum (low dose)

Primary outcome

Change in microbial composition following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days
Time frame: 15 days post intervention
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.
Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days
Time frame: 15 days post intervention
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.
Change in Skin quality parameters following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days
Time frame: 15 days post intervention
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.
Change in Skin quality parameters following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days
Time frame: 15 days post intervention
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.
Change in microbial composition following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days
Time frame: 29 days post intervention
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.
Change in Skin quality parameters following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days
Time frame: 29 days post intervention
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.
Change in microbial composition following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days
Time frame: 29 days post intervention
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.
Change in Skin quality parameters following application of 1e6 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 29 days
Time frame: 29 days post intervention
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.
Change in microbial composition post 7 days of last application of 1e8 cfu of Micrococcus luteus Q24 in serum
Time frame: 7 days post last intervention
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.
Change in microbial composition post 7 days of last application of 1e6 cfu of Micrococcus luteus Q24 in serum
Time frame: 7 days post last intervention
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.
Change in Skin quality parameters post 7 days of last application of 1e8 cfu of Micrococcus luteus Q24 in serum
Time frame: 7 days post last intervention
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.
Change in Skin quality parameters post 7 days of last application of 1e6 cfu of Micrococcus luteus Q24 in serum
Time frame: 7 days post last intervention
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
Background: PubMed 25279917Oh 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.
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.
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.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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: finished, as of the sponsor's last update on 18 May 2025. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in microbial composition following application of 1e8 cfu per dose Micrococcus luteus Q24 in serum from Day 0 (baseline) to 15 days (time frame: 15 days post intervention). The study lists 12 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 NCT06166979, which also lists 3 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 18 May 2025.