The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne

Study Overview
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Brief Summary
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The purpose of this study is to evaluates how probiotics and dietary supplementation with an herbal powder can shift the gut microbiome in those with non-cystic acne vulgaris.

Detailed Description
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The investigators hope to evaluate the effects of oral supplements in changing intestinal health and the gut bacteria in patients with non-cystic acne vulgaris. Acne is a chronic inflammatory condition that is estimated to affect greater than 85% of the population at some point. While antibiotics are typically used for systemic therapy, it can increase the risk for drug-resistant bacteria and shift the gut microbiome in a negative way. On the other hand, probiotics and dietary supplementation have been shown to support the gut microbiome. In this study, participants will be randomized to either receiving a probiotic or powder supplement. This means that participants will have an equal chance of receiving either product as half of the participants will be randomized to receive only oral probiotic, and the other half will receive oral supplement powder.

Official Title
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The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne

Conditions
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Acne Vulgaris, Acneiform Eruptions, Skin Diseases, Sebaceous Gland Diseases

Intervention / Treatment
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* Other: Probiotic
* Dietary Supplement: Oral herbal powder supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 12 years of age until 45 years of age The presence of mild to moderate acne based on investigator global assessment. Presence of at least 10 inflammatory lesions and at least 5 non-inflammatory lesions Exclusion Criteria: The presence of severe acne as noted by the investigator global assessment. Those who are unwilling to discontinue oral probiotic-based supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment. Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide for 2 weeks prior to enrollment Those who are unwilling to keep their facial regimen the same throughout the study Individuals who have been on an oral antibiotic for acne within the previous one month. Individuals who are pregnant or breastfeeding. Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study. Individuals on oral contraceptive pills or progesterone or estrogen containing therapies Use of isotretinoin within the three months prior to enrollment. Individuals on finasteride or dutasteride Current tobacco smoker or a tobacco smoking history

Ages Eligible for Study
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Minimum Age: 12 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Daily consumption of probiotic | Other: Probiotic<br>* Oral probiotic<br>|
| Experimental: Oral herbal supplement<br>Daily consumption of oral herbal supplement powder | Dietary Supplement: Oral herbal powder supplement<br>* oral herbal powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiome diversity | Change on the Shannon diversity of the gut microbiome | 4 weeks | 
| Sebum excretion rate | Measure of skin sebum via sebumeter | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diurnal Cortisol Slope | 4 point salivary cortisol collections to assess diurnal slope | 4 weeks | 
| Diurnal Cortisol Slope | 4 point salivary cortisol collections to assess diurnal slope | 8 weeks | 
| Salivary Dihydrotestosterone | Salivary collection to assess dihydrotestosterone | 4 weeks | 
| Salivary Dihydrotestosterone | Salivary collection to assess dihydrotestosterone | 8 weeks | 
| Gut microbiome diversity | Change on the Shannon diversity of the gut microbiome | 8 weeks | 
| Sebum excretion rate | Measure of skin sebum via sebumeter | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, probiotics, dietary supplementation