The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne
NCT ID: NCT05919810
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2023-07-03
2024-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Probiotic
Daily consumption of probiotic
Probiotic
Oral probiotic
Oral herbal supplement
Daily consumption of oral herbal supplement powder
Oral herbal powder supplement
oral herbal powder
Interventions
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Probiotic
Oral probiotic
Oral herbal powder supplement
oral herbal powder
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
45 Years
ALL
Yes
Sponsors
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Codex Labs
UNKNOWN
Integrative Skin Science and Research
INDUSTRY
Responsible Party
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Principal Investigators
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Raja Sivamani, MD MS AP
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Integrative Skin Science and Research
Sacramento, California, United States
Countries
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References
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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.
Other Identifiers
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CB_Acne_Supp
Identifier Type: -
Identifier Source: org_study_id