The Influence of Oral Probiotics on the Microbiome and Lipidome

NCT03605108 | Completed DMC

• 1 other identifier: 1242039
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiome; Skin Microbiome; Gut Lipidome; Skin Lipidome; Blood Lipidome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gut Microbiome Changes

  8 weeks +/- 1 week

• Sebum Production

  8 weeks +/- 1 week

• Hydration

  8 weeks +/- 1 week

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

• 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

Placebo

PLACEBO COMPARATOR

Rice flour only

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

• 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.

Probiotic

Placebo OTHER

Rice flour only

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 18 years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Raja K. Sivamani, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 30, 2018
• Study Start: June 29, 2018
• Primary Completion: May 9, 2019
• Study Completion: May 9, 2019
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

US (1)