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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-24

Study Completion Date

2023-04-12

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 elbow and back of forearm in a topical balm format in healthy adults.

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Detailed Description

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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

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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 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).

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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Study Group A: Blis Q24 balm (Active)

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

Group Type ACTIVE_COMPARATOR

Micrococcus luteus Blis Q24 balm

Intervention Type OTHER

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

Study Group B: Placebo balm (without Blis Q24)

Group A: Placebo balm

Group Type PLACEBO_COMPARATOR

Placebo balm

Intervention Type OTHER

Placebo balm formulation for topical applications.

Interventions

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Micrococcus luteus Blis Q24 balm

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

Intervention Type OTHER

Placebo balm

Placebo balm formulation for topical applications.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes