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| Name | Class |
|---|---|
| Codex Labs | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Daily consumption of probiotic |
|
| Oral herbal supplement | Experimental | Daily consumption of oral herbal supplement powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Other | Oral probiotic |
| |
| Oral herbal powder supplement |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome composition of short chain fatty acid producing bacteria | Change on the relative abundance of Akkermansia mucinaphila and Facelibacterium pruasntizii | 8 weeks |
| Stool acetate levels | Assess the short chain fatty acid stool acetate levels | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in salivary progesterone levels | Progesterone and 17-OH progesterone levels | 4 weeks |
| Change in salivary progesterone levels | Progesterone and 17-OH progesterone levels |
| Measure | Description | Time Frame |
|---|---|---|
| Total lesion count | Safety endpoint to count inflammatory and non-inflammatory lesions | 4 weeks |
| Total lesion count | Safety endpoint to count inflammatory and non-inflammatory lesions |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raja Sivamani, MD MS AP | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Sacramento | California | 95819 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40246799 | Derived | Min M, Afzal N, Maloh J, Dulai AS, Ahmad N, Pinzauti D, Sivamani RK. Prospective Comparative Study of an Oral Synbiotic and a Myoinositol-Based Herbal Supplement in Modifying Hormone Levels and the Gut Microbiome in Non-cystic Acne. Dermatol Ther (Heidelb). 2025 Jun;15(6):1331-1350. doi: 10.1007/s13555-025-01411-4. Epub 2025 Apr 18. |
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| Dietary Supplement |
oral herbal powder |
|
| 8 weeks |
| 8 weeks |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D012625 | Sebaceous Gland Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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