Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris

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: Unknown
• Conditions: Acne Vulgaris
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

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: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 43 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome changes	Evaluation of alpha diversity	4 weeks and 8 weeks
Change in skin microbiome	Relative abundance cutibacterium genera	12 weeks
Safety assessments for GI distress	Self assessment using Digestive Questionnaire	4 weeks, 8 weeks, 12 weeks
Change in sebum excretion rate	Sebumeter: 0-150 micrograms/cm^2	4 weeks, 8 weeks, 12 weeks
Change in skin hydration	Moisturemeter: 0-150	4,8 and 12 weeks
Change in skin pH	Use of pH meter	4,8, and 12 weeks
Facial redness - Image based	BTBP Clarity Mini 3D camera	4,8,12 weeks
Facial skin tone - Image based	BTBP Clarity Mini 3D camera	4,8,12 weeks
Subjective assessment of the skin	Self-assessment through Dermatology Quality of Life questionnaire	4,8,12 weeks
Safety assessment of acne	Evaluation of acne to assess for flares	4, 8, 12 weeks
Gut Microbiome Changes	Relative abundance of Akkermansia muciniphila	4, 8, 12 weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Microbiome labs

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: skin; dermatology; probiotics; microbiome; acne; acne vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID 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