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

February 20, 2023 updated by: BLIS Technologies Limited
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
    • Otago
      • Dunedin, Otago, New Zealand, 9012
        • Recruiting
        • Blis Technologies Ltd
        • Principal Investigator:
          • Rohit Jain, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Study Group A: Blis Q24 balm (Active)
Group A: Probiotic Micrococcus luteus Q24 balm (dose: 1e7 colony forming units per application)
Other: Micrococcus luteus Blis Q24 balm
Balm formulation containing probiotic bacteria Micrococcus luteus Q24 for topical applications.
Placebo Comparator: Study Group B: Placebo balm (without Blis Q24)
Group A: Placebo balm
Other: Placebo balm
Placebo balm formulation for topical applications.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
11 days post intervention
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.
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.
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.
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
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.
7 days post last intervention
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.
11 days post last intervention
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.
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.
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.
7 days post last intervention
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.
7 days post last intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BLIS Technologies Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BLTCT2022/8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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