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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Diseases; Acne Vulgaris; Acneiform Eruptions; Sebaceous Gland Diseases
• Intervention / Treatment: Other: Probiotic; Dietary supplement: Oral herbal powder supplement

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 Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nasima Afzal; Phone Number: 9167502463; Email: nasima@integrativeskinresearch.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95819
      • Recruiting
      • Integrative Skin Science and Research
      • Contact: Nasima Afzal; Phone Number: 916-750-2463; Email: nasima@integrativeskinresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome diversity	Change on the Shannon diversity of the gut microbiome	4 weeks
Sebum excretion rate	Measure of skin sebum via sebumeter	4 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total lesion count	Safety endpoint to count inflammatory and non-inflammatory lesions	4 weeks
Total lesion count	Safety endpoint to count inflammatory and non-inflammatory lesions	8 weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Codex Labs
• Investigators: Principal Investigator: Raja Sivamani, MD MS AP, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Estimated): December 19, 2023
• Study Completion (Estimated): March 19, 2024

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: probiotics; dietary supplementation; microbiome
• Additional Relevant MeSH Terms: Acne Vulgaris; Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases
• Other Study ID Numbers: CB_Acne_Supp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No