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

Integrative Skin Science and Research

Status: Completed

Conditions: Skin Diseases; Acneiform Eruptions; Acne Vulgaris; Sebaceous Gland Diseases

Treatments: Dietary Supplement: Oral herbal powder supplement; Other: Probiotic

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05919810

CB_Acne_Supp

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Probiotic

Experimental group

Description:

Daily consumption of probiotic

Treatment:

Other: Probiotic

Oral herbal supplement

Experimental group

Description:

Daily consumption of oral herbal supplement powder

Treatment:

Dietary Supplement: Oral herbal powder supplement