Skip to main content
OpenTrials
Completed

NCT Number: NCT05919810

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Skin Science and Research

Sacramento, California, 95819, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Other

Oral probiotic

Oral herbal powder supplement

Dietary Supplement

oral herbal powder

Primary outcomes

  1. Gut microbiome composition of short chain fatty acid producing bacteria

    Time frame: 8 weeks

    Change on the relative abundance of Akkermansia mucinaphila and Facelibacterium pruasntizii

  2. Stool acetate levels

    Time frame: 8 weeks

    Assess the short chain fatty acid stool acetate levels

Secondary outcomes

  1. Change in salivary progesterone levels

    Time frame: 4 weeks

    Progesterone and 17-OH progesterone levels

  2. Change in salivary progesterone levels

    Time frame: 8 weeks

    Progesterone and 17-OH progesterone levels

Other outcomes

  1. Total lesion count

    Time frame: 4 weeks

    Safety endpoint to count inflammatory and non-inflammatory lesions

  2. Total lesion count

    Time frame: 8 weeks

    Safety endpoint to count inflammatory and non-inflammatory lesions

Sponsors and collaborators

Lead sponsor

Integrative Skin Science and Research

Industry

Collaborators

  • Codex Labs

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.