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

Primary Purpose

Acne Vulgaris, Acneiform Eruptions, Skin Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotic
Oral herbal powder supplement
Sponsored by
Integrative Skin Science and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring microbiome, probiotics, dietary supplementation

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • Integrative Skin Science and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Probiotic

Oral herbal supplement

Arm Description

Daily consumption of probiotic

Daily consumption of oral herbal supplement powder

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 16, 2023
Last Updated
July 24, 2023
Sponsor
Integrative Skin Science and Research
Collaborators
Codex Labs
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1. Study Identification

Unique Protocol Identification Number
NCT05919810
Brief Title
The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne
Official Title
The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
December 19, 2023 (Anticipated)
Study Completion Date
March 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integrative Skin Science and Research
Collaborators
Codex Labs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Acneiform Eruptions, Skin Diseases, Sebaceous Gland Diseases
Keywords
microbiome, probiotics, dietary supplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Daily consumption of probiotic
Arm Title
Oral herbal supplement
Arm Type
Experimental
Arm Description
Daily consumption of oral herbal supplement powder
Intervention Type
Other
Intervention Name(s)
Probiotic
Intervention Description
Oral probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral herbal powder supplement
Intervention Description
oral herbal powder
Primary Outcome Measure Information:
Title
Gut microbiome diversity
Description
Change on the Shannon diversity of the gut microbiome
Time Frame
4 weeks
Title
Sebum excretion rate
Description
Measure of skin sebum via sebumeter
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Diurnal Cortisol Slope
Description
4 point salivary cortisol collections to assess diurnal slope
Time Frame
4 weeks
Title
Diurnal Cortisol Slope
Description
4 point salivary cortisol collections to assess diurnal slope
Time Frame
8 weeks
Title
Salivary Dihydrotestosterone
Description
Salivary collection to assess dihydrotestosterone
Time Frame
4 weeks
Title
Salivary Dihydrotestosterone
Description
Salivary collection to assess dihydrotestosterone
Time Frame
8 weeks
Title
Gut microbiome diversity
Description
Change on the Shannon diversity of the gut microbiome
Time Frame
8 weeks
Title
Sebum excretion rate
Description
Measure of skin sebum via sebumeter
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Total lesion count
Description
Safety endpoint to count inflammatory and non-inflammatory lesions
Time Frame
4 weeks
Title
Total lesion count
Description
Safety endpoint to count inflammatory and non-inflammatory lesions
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasima Afzal
Phone
9167502463
Email
nasima@integrativeskinresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD MS AP
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasima Afzal
Phone
916-750-2463
Email
nasima@integrativeskinresearch.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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