Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris

November 20, 2020 updated by: Raja Sivamani, Integrative Skin Science and Research

Prospective Randomized Double-Blind Placebo-Controlled Study of Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris

The purpose of this study is to determine how probiotics affect sebum production and gut health in those with acne vulgaris.

Study Overview

Status

Status

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

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

Probiotics have been shown in previous pilot studies to be helpful in acne and this study aims to examine how the gut microbiome and skin biophysical properties are shifted in those with acne vulgaris. In particular, this study will assess the influence of oral spore based probiotics on the skin sebum production and will assess how probiotics influence the gut microbiome and the blood levels of short chain fatty acids.

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.
70

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

  • United States
    • California
      • Sacramento, California, United States, 95815
        • Recruiting
        • Integrative Skin Science and Research

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

9 years to 41 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects aged 13-45
  • Subjects with acne vulgaris as diagnosed by a board-certified dermatologist,having mild-moderate acne on the face with an IGA score of 2-3 and 10+ inflammatory lesions on face and 15+ total lesions.
  • Subjects should experience new acne lesions on a recurrent basis within last 6 months
  • Must be willing to comply with all protocol requirements
  • Must be willing to have flash photo facial images taken with the imaging systems
  • Males must be willing to shave any facial hair

Exclusion Criteria:

  • Any systemic antibiotics used to treat acne (injected or oral)within 6 months of starting study. Any 14-day or shorter course of systemic antibiotics (injected or oral) used to treat conditions other than acne within 1 month of starting study
  • Any topical antibiotic or benzoyl peroxide within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or benzoyl peroxide ingredient.
  • Any oral probiotic or prebiotic supplementation within past 1 month
  • Subjects must have no history of malignancy or cancer or diagnosis of gastrointestinal inflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis)
  • Has a condition or is on medication the investigator and/or designee believe could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results
  • Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating, or post-menopausal.
  • Is participating in a concurrent clinical research study or has participated in acne or other facial study at this or any other facility in the past 4 weeks
  • Those with BMI higher than 35kg/m²
  • Those that have undergone a change in hormonally based therapies, such as but not limited to oral contraceptive pills or progesterone based pills within the last two months. Progesterone releasing IUDs and spironolactone are considered hormone-based therapy.
  • Commencement of a new diet (such as the ketogenic diet)or supplements within the 1 month prior to initiating participation, at the discretion of the investigator.
  • Use of medications that alter blood lipids, such as statins and anti-hyperlipidemic medications
  • Is participating in or has participated in acne or other facial study at this or any other facility in the past 4 weeks. Participation in survey-based studies are approved at the discretion of the investigator.
  • Has a skin disease on face, other than acne, that will interfere with image collection and assessment in the opinion of the investigator
  • Refusal to shave or remove facial hair that may interfere with image collection and assessment.
  • Severe acne or nodulocystic acne, at the discretion of the investigator
  • Use of isotretinoin within the 6 months prior to starting in study.
  • Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, or artificial tanning.
  • Known allergy or irritation to the supplement or facial products utilized in the study
  • Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
  • Prisoners
  • Adults unable to consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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.
Placebo Comparator: Placebo
Participants will be taking a placebo supplement that they will be taking by mouth once per day.
Dietary supplement: Placebo
Placebo caps
Experimental: Probiotic
Participants will be taking a probiotic supplement that they will be taking by mouth once per day.
Dietary supplement: Probiotic
Bacillus Subtilis, Bacillus Clausii, Bacillus Coagulans, Bacillus Indicus HU36, MCC 102

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
Microbiota Diversity
Time Frame: 12 weeks
Evaluation of alpha diversity
12 weeks
Short chain fatty acids
Time Frame: 12 weeks
Blood plasma
12 weeks
Blood acetate levels
Time Frame: 12 weeks
Blood plasma
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gut microbiome changes
Time Frame: 4 weeks and 8 weeks
Evaluation of alpha diversity
4 weeks and 8 weeks
Change in skin microbiome
Time Frame: 12 weeks
Relative abundance cutibacterium genera
12 weeks
Safety assessments for GI distress
Time Frame: 4 weeks, 8 weeks, 12 weeks
Self assessment using Digestive Questionnaire
4 weeks, 8 weeks, 12 weeks
Change in sebum excretion rate
Time Frame: 4 weeks, 8 weeks, 12 weeks
Sebumeter: 0-150 micrograms/cm^2
4 weeks, 8 weeks, 12 weeks
Change in skin hydration
Time Frame: 4,8 and 12 weeks
Moisturemeter: 0-150
4,8 and 12 weeks
Change in skin pH
Time Frame: 4,8, and 12 weeks
Use of pH meter
4,8, and 12 weeks
Facial redness - Image based
Time Frame: 4,8,12 weeks
BTBP Clarity Mini 3D camera
4,8,12 weeks
Facial skin tone - Image based
Time Frame: 4,8,12 weeks
BTBP Clarity Mini 3D camera
4,8,12 weeks
Subjective assessment of the skin
Time Frame: 4,8,12 weeks
Self-assessment through Dermatology Quality of Life questionnaire
4,8,12 weeks
Safety assessment of acne
Time Frame: 4, 8, 12 weeks
Evaluation of acne to assess for flares
4, 8, 12 weeks
Gut Microbiome Changes
Time Frame: 4, 8, 12 weeks
Relative abundance of Akkermansia muciniphila
4, 8, 12 weeks

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.
Integrative Skin Science and Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Microbiome labs

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.
May 11, 2020

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 1, 2021

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.
March 1, 2021

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).
October 9, 2020

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.
October 15, 2020

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.
October 22, 2020

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.
November 24, 2020

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.
November 20, 2020

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.
November 1, 2020

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.
  • ISSR-Prob-GutSkin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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