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| Name | Class |
|---|---|
| Microbiome labs | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will be taking a placebo supplement that they will be taking by mouth once per day. |
|
| Probiotic | Experimental | Participants will be taking a probiotic supplement that they will be taking by mouth once per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Bacillus Subtilis, Bacillus Clausii, Bacillus Coagulans, Bacillus Indicus HU36, MCC 102 |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome changes | Evaluation of alpha diversity | 4 weeks and 8 weeks |
| Change in skin microbiome | Relative abundance cutibacterium genera |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raja K Sivamani, MD | Contact | 916-524-1216 | raja.sivamani@integrativeskinresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Recruiting | Sacramento | California | 95815 | United States |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Double-blind, randomized, placebo-controlled
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| Placebo | Dietary Supplement | Placebo caps |
|
| 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 |
| D019602 |
| Food and Beverages |