The Influence of Oral Probiotics on the Microbiome and Lipidome

Not Applicable

Completed

• Conditions: Gut Microbiome; Blood Lipidome; Gut Lipidome; Skin Microbiome; Skin Lipidome
• Interventions: Other: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT03605108
• Lead Sponsor: University of California, Davis

Brief Summary

The purpose of this study is to measure oil production of the face, facial properties, and gut bacteria in people being given oral probiotics. Probiotic supplements contain active cultures of bacteria that are thought to be beneficial to human health.The investigators want to find out if probiotics taken by mouth alter the bacteria in subject's gut and subject's skin oil production compared to a placebo. This is a single blind study and subject may receive a probiotic or a placebo for the first half of the study and a placebo or a probiotic for the second half of the study. Subject will not know what was given to participants.

Detailed Description

Antibiotics are widely used within dermatology for the treatment of chronic skin conditions such as acne, rosacea, and atopic dermatitis. Previous studies have shown that oral probiotics may be beneficial for skin disesaes such as atopic dermatitis and acne, but a mechanism for how the gut communicates to the skin remains elusive.

The balance between short chain fatty acids and long chain fatty acids has been proposed as one factor in how bacteria in the gut are able to communicate with the rest of the body. Studies in Dr. Sivamani's lab have shown that subjects with acne have a reduced level of short chain fatty acids in their blood when compared to age-matched control (unpublished).

The aim of this study is to understand how oral probiotics may alter the gut microbiome and if they can augment the short chain fatty acids in the blood lipidome. Ultimately, the investigator's goal is to find suitable alternatives for the use of antibiotics in the treatment of chronic skin conditions so that the amount of antibiotics that are in use can be reduced.

Study Timeline

• Study Start: 2018-06-29
• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-30
• Primary Completion: 2019-05-09
• Study Completion: 2019-05-09
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-10
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Rice flour only
Probiotic	Probiotic	• Probiotic fomula per capsule: 2 Billion CFUs HU36 - 30 mg HU58 - 20 mg Bacillus clausii -25 mg Bacillus coagulans 10B - 35 mg Prepro - 22 mg. The prebiotic that is to be used in the proprietary blend is a vegetable grade cellulose.

Primary Outcome Measures

Name	Time	Method
Blood Lipidome Changes	8 weeks +/- 1 week	The primary objective is to assess if probiotics rich in the production of short chain fatty acids can shift the blood lipidome to have a higher level of short chain fatty acids

Secondary Outcome Measures

Name	Time	Method
Hydration	8 weeks +/- 1 week	Hydration will be measured via Moisturemeter device that will measure hydration in arbitrary units (AU)
Gut Microbiome Changes	8 weeks +/- 1 week	Specifically the presence of short chain fatty acid producing bacteria
Sebum Production	8 weeks +/- 1 week	Sebum production will be measured via Sebumeter device that will calculate sebum in micrograms/centimeter\^2

Trial Locations

Locations (1)

UC Davis Department of Dermatology; 🇺🇸 Sacramento, California, United States