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

NCT04841694 | Unknown

• 1 other identifier: PROB-CAROT
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Human Microbiome

Keywords

gut microbiome; dermatology; skin; carotenoids; probiotics

Outcome Measures

Primary Outcomes (1)

• Carotenoid Levels

  Change in skin carotenoid level and blood carotenoid level with supplementation

  5 weeks

Secondary Outcomes (10)

• Gut Microbiome Changes

  Week 5

• Assessment of GI related gas and constipation

  Week 5

• Assessment of GI related gas and constipation

  Week 6

• Shift in facial redness- image based

  Week 5

• Shift in facial redness- image based

  Week 6

Study Arms (1)

Probiotic

EXPERIMENTAL

Participants will be taking a probiotic supplement that they will be taking by mouth once per day

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Bacillus indicus

Probiotic

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• Microbiome labs: collaborator

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Raja K Sivamani, MD

CONTACT

916-524-1216; raja.sivamani@integrativeskinresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 12, 2021
• Study Start: June 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)