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

Last updated: December 15, 2024
Sponsor: Integrative Skin Science and Research
Overall Status: Completed

Phase

N/A

Condition

Acne

Rash

Scalp Disorders

Treatment

Probiotic

Oral herbal powder supplement

Clinical Study ID

NCT05919810
CB_Acne_Supp
  • Ages 12-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • The presence of severe acne as noted by the investigator global assessment.

  • Those who are unwilling to discontinue oral probiotic-based supplementation, orsupplement ingredients found in the study's oral product 1 month prior toenrollment.

  • Those who are unwilling to discontinue topical antibiotics and topical benzoylperoxide 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 onemonth.

  • Individuals who are pregnant or breastfeeding.

  • Individuals who have changed any of their hormonal based contraception or therapieswithin 3 months prior to joining the study.

  • Individuals on oral contraceptive pills or progesterone or estrogen containingtherapies

  • Use of isotretinoin within the three months prior to enrollment.

  • Individuals on finasteride or dutasteride

  • Current tobacco smoker or a tobacco smoking history

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Probiotic
Phase:
Study Start date:
July 03, 2023
Estimated Completion Date:
July 31, 2024

Study 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.

Connect with a study center

  • Integrative Skin Science and Research

    Sacramento, California 95819
    United States

    Site Not Available

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