The Influence of Oral Probiotics on the Microbiome and Lipidome

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.

Study Overview

• Status: Completed
• Conditions: Gut Microbiome; Skin Microbiome; Gut Lipidome; Skin Lipidome; Blood Lipidome
• Intervention / Treatment: Dietary supplement: Probiotic; Other: Placebo

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subjects with acne have a reduced level of short chain fatty acids in their blood when compared to age-matched control (unpublished).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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • UC Davis Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• 18 years of age or older

Exclusion criteria

• Those on oral antibiotics within a month of initiating the study.
• Subjects must have no history of diabetes, known cardiovascular disease, known immunocompromised condition, malignancy, kidney disease, or chronic steroid use.
• Subjects must have no history or diagnosis of gastrointestinal inflammatory diseases.
• Those with BMI higher than 30 kg/m²
• Those on topical medications to the face such as retinoids or antibiotics who are not willing or medical unable (in the judgement of the investigator) to discontinue use for two weeks prior to the study and for the duration of study participation.
• Those that have undergone a change in hormonally based therapies, such as but not limited to oral contraceptive pills or progesterone based pills within the last two months. Progesterone releasing IUDs are considered hormone releasing therapy.
• Use of medications that alter blood lipids, such as statins and anti-hyperlipidemic medications
• Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
• Pregnant women
• Prisoners
• Adults unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: 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.
Placebo Comparator: Placebo; Rice flour only	Other: Placebo; Rice flour only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Lipidome Changes	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	8 weeks +/- 1 week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Raja K. Sivamani, MD, UC Davis

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Actual): May 9, 2019
• Study Completion (Actual): May 9, 2019

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1242039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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