Clinical trial NCT05919810: The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne
Official title: The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Keywords: microbiome
probiotics
dietary supplementation
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Codex Labs
First posted: 2023-06-26
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gut microbiome composition of short chain fatty acid producing bacteria
timeFrame: 8 weeks
measure: Stool acetate levels
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in salivary progesterone levels
timeFrame: 4 weeks
measure: Change in salivary progesterone levels
timeFrame: 8 weeks
Other outcomes:
measure: Total lesion count
timeFrame: 4 weeks
measure: Total lesion count
timeFrame: 8 weeks
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
affiliation: Principal Investigator
name: Raja Sivamani, MD MS AP
role: PRINCIPAL_INVESTIGATOR
References: