Oral Probiotics on the Shift in Gut Microbiome and Skin Carotenoid Levels

Prospective Randomized Double-Blind Placebo Controlled Study of Oral Probiotics on the Shift of Gut Microbiome and Skin Carotenoid Levels

The purpose of this study is to determine how probiotics affects circulating carotenoid levels.

Study Overview

• Status: Not yet recruiting
• Conditions: Human Microbiome
• Intervention / Treatment: Dietary supplement: Probiotic

Detailed Description

Certain probiotic strains are rich in the production of carotenoids. This study will evaluate if probiotic supplementation with a carotenoid rich strain will augment circulating carotenoids.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects aged 40+
• Must be willing to comply with all protocol requirements
• Must be willing to have flash photo facial images taken with the imaging systems
• Fitzpatrick skin type II, III, or IV

Exclusion Criteria:

• Any systemic or antibiotics (injected or oral) within 6 months of starting study
• Any topical antibiotic or Vitamin A within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or vitamin A ingredient.
• Any oral probiotic or prebiotic supplementation within past 1 month at the discretion of the investigator.
• Limit total fruit and vegetable intake to 2.5 servings (1 serving=1 cup) per day of high carotenoid foods. High carotenoid foods include spinach, summer squash, carrots, citrus fruits, celery, kale, tomatoes, and cantaloupe
• Subjects must have no history of malignancy or cancer (excluding skin cancer unless there is a history of metastasis) or diagnosis of gastrointestinal inflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis)
• Has a condition or is on medication the investigator and/or designee believe could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results
• Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating.
• Is participating in a concurrent intervention based clinical research study
• Those with BMI higher than 35 kg/m²
• Commencement of a new diet (such as the ketogenic diet) or supplements within the 1 month prior to initiating participation, at the discretion of the investigator.
• Is participating in or has participated in a intervention based facial study at this or any other facility in the past 2 weeks. Participation in survey-based studies are approved at the discretion of the investigator.
• Has a skin disease on face that will interfere with image collection and assessment in the opinion of the investigator
• Refusal to shave or remove facial hair that may interfere with image collection and assessment.
• Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, sun tanning, or artificial tanning.
• Known allergy or irritation to the supplement utilized in the study
• Persons unwilling to avoid sun exposure to the inner forearm
• Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
• Cutaneous photosensitivity at wavelengths of 400-450 nm
• Porphyria or known allergies to porphyrins
• Prisoners
• Adults unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Probiotic; Participants will be taking a probiotic supplement that they will be taking by mouth once per day	Dietary supplement: Probiotic; Bacillus indicus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotenoid Levels	Change in skin carotenoid level and blood carotenoid level with supplementation	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotenoid Levels	Change in skin carotenoid level and blood carotenoid level with supplementation	5 weeks
Gut Microbiome Changes	Shift in gut microbiome diversity	Week 5
Assessment of GI related gas and constipation	self assessment using digestive health questionnaire	Week 5
Assessment of GI related gas and constipation	self assessment using digestive health questionnaire	Week 6
Shift in facial redness- image based	BTBP Clarity Mini 3D camera	Week 5
Shift in facial redness- image based	BTBP Clarity Mini 3D camera	Week 6
Shift in facial pigmentation - image based	BTBP Clarity Mini 3D camera	Week 5
Shift in facial pigmentation - image based	BTBP Clarity Mini 3D camera	Week 6
Protection against blue light exposure induced change in skin color	Change in skin color measured by a skin colorimeter	Weeks 5
Protection against blue light exposure induced change in skin color	Change in skin color measured by a skin colorimeter	Weeks 6

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Microbiome labs

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2021
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (ACTUAL): April 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: skin; dermatology; probiotics; gut microbiome; carotenoids
• Other Study ID Numbers: PROB-CAROT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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