Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris

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

Detailed Description
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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.

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, randomized, placebo-controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants will be taking a placebo supplement that they will be taking by mouth once per day. | Dietary Supplement: Placebo<br>* Placebo caps<br>|
| Experimental: Probiotic<br>Participants will be taking a probiotic supplement that they will be taking by mouth once per day. | Dietary Supplement: Probiotic<br>* Bacillus Subtilis, Bacillus Clausii, Bacillus Coagulans, Bacillus Indicus HU36, MCC 102<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne vulgaris, skin, dermatology, acne, microbiome, probiotics