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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05919810
• Other study ID #: CB_Acne_Supp
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 3, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Integrative Skin Science and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: July 31, 2024
• Est. primary completion date: February 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris
• Acneiform Eruptions
• Sebaceous Gland Diseases
• Skin Diseases

Intervention

Other:
• Probiotic
Oral probiotic

Dietary Supplement:
• Oral herbal powder supplement
oral herbal powder

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Codex Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total lesion count	Safety endpoint to count inflammatory and non-inflammatory lesions	4 weeks
Other	Total lesion count	Safety endpoint to count inflammatory and non-inflammatory lesions	8 weeks
Primary	Gut microbiome diversity	Change on the Shannon diversity of the gut microbiome	4 weeks
Primary	Sebum excretion rate	Measure of skin sebum via sebumeter	4 weeks
Secondary	Diurnal Cortisol Slope	4 point salivary cortisol collections to assess diurnal slope	4 weeks
Secondary	Diurnal Cortisol Slope	4 point salivary cortisol collections to assess diurnal slope	8 weeks
Secondary	Salivary Dihydrotestosterone	Salivary collection to assess dihydrotestosterone	4 weeks
Secondary	Salivary Dihydrotestosterone	Salivary collection to assess dihydrotestosterone	8 weeks
Secondary	Gut microbiome diversity	Change on the Shannon diversity of the gut microbiome	8 weeks
Secondary	Sebum excretion rate	Measure of skin sebum via sebumeter	8 weeks