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

Not Applicable

Completed

• Conditions: Acneiform Eruptions; Acne Vulgaris; Skin Diseases; Sebaceous Gland Diseases
• Interventions: Dietary Supplement: Oral herbal powder supplement; Other: Probiotic

• Registration Number: NCT05919810
• Lead Sponsor: Integrative Skin Science and Research

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.

Study Timeline

• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-06-16
• Study First Posted: 2023-06-26
• Study Start: 2023-07-03
• Primary Completion: 2024-02-12
• Status Verified: 2024-05
• Study Completion: 2024-07-31
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral herbal supplement	Oral herbal powder supplement	Daily consumption of oral herbal supplement powder
Probiotic	Probiotic	Daily consumption of probiotic

Primary Outcome Measures

Name	Time	Method
Gut microbiome composition of short chain fatty acid producing bacteria	8 weeks	Change on the relative abundance of Akkermansia mucinaphila and Facelibacterium pruasntizii
Stool acetate levels	8 weeks	Assess the short chain fatty acid stool acetate levels

Secondary Outcome Measures

Name	Time	Method
Change in salivary progesterone levels	8 weeks	Progesterone and 17-OH progesterone levels

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States