Colonization of Skin by M. Luteus Q24 Probiotic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-03-15

Brief Summary

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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 face from a serum format in healthy adults.

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Detailed Description

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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 and to evaluate the changes in skin quality parameters following topical application of probiotic in a serum format.

Conditions

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Microbial Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of two groups applying serum containing Micrococcus luteus Q24 at a low or higher dose of probiotic.

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

Group B: Probiotic Micrococcus luteus Q24 serum (dose:1e6 colony forming units per application of serum)

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

A Staff member will be assigned to distribute blinded samples. The investigator will not be aware of the dose groups.

Study Groups

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Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active)

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

Group Type ACTIVE_COMPARATOR

Active Comparator: Study Group A: Blis Q24 Serum at higher dose

Intervention Type OTHER

Active Comparator: Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active)

Study Group B: Blis Q24 Serum at 1e6 cfu/ dose (Active)

Group B: Probiotic Micrococcus luteus Q24 serum (dose: 1e6 colony forming units per application)

Group Type ACTIVE_COMPARATOR

Active Comparator: Study Group B: Blis Q24 Serum at lower dose

Intervention Type OTHER

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

Interventions

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Active Comparator: Study Group A: Blis Q24 Serum at higher dose

Active Comparator: Study Group A: Blis Q24 Serum at 1e7 cfu/ dose (Active)

Intervention Type OTHER

Active Comparator: Study Group B: Blis Q24 Serum at lower dose

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. In general good health 18 - 80 years of age.
2. Practice good general body hygiene.

Exclusion Criteria

1. Have a history of autoimmune disease or are immunocompromised (have a weakened immune system).
2. Are on concurrent antibiotic therapy or regular antibiotic use within the last 1 week.
3. People with allergies or sensitivity to dairy.
4. People with an open wound on the Blis Q24 application sites.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes