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

Sponsor

Integrative Skin Science and Research (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05919810

Collaborator

Codex Labs (Other)

Enrollment

Location

Arms

8.8

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases	Other: Probiotic Dietary Supplement: Oral herbal powder supplement	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 26, 2023

Anticipated Primary Completion Date :

Dec 19, 2023

Anticipated Study Completion Date :

Mar 19, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic Daily consumption of probiotic	Other: Probiotic Oral probiotic
Experimental: Oral herbal supplement Daily consumption of oral herbal supplement powder	Dietary Supplement: Oral herbal powder supplement oral herbal powder

Arm

Intervention/Treatment

Experimental: Probiotic

Daily consumption of probiotic

Other: Probiotic

Oral probiotic

Experimental: Oral herbal supplement

Daily consumption of oral herbal supplement powder

Dietary Supplement: Oral herbal powder supplement

oral herbal powder

Outcome Measures

Primary Outcome Measures

Gut microbiome diversity [4 weeks]
Change on the Shannon diversity of the gut microbiome
Sebum excretion rate [4 weeks]
Measure of skin sebum via sebumeter

Secondary Outcome Measures

Diurnal Cortisol Slope [4 weeks]
4 point salivary cortisol collections to assess diurnal slope
Diurnal Cortisol Slope [8 weeks]
4 point salivary cortisol collections to assess diurnal slope
Salivary Dihydrotestosterone [4 weeks]
Salivary collection to assess dihydrotestosterone
Salivary Dihydrotestosterone [8 weeks]
Salivary collection to assess dihydrotestosterone
Gut microbiome diversity [8 weeks]
Change on the Shannon diversity of the gut microbiome
Sebum excretion rate [8 weeks]
Measure of skin sebum via sebumeter

Other Outcome Measures

Total lesion count [4 weeks]
Safety endpoint to count inflammatory and non-inflammatory lesions
Total lesion count [8 weeks]
Safety endpoint to count inflammatory and non-inflammatory lesions

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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