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

Human Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04841694
• Other study ID #: PROB-CAROT
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: March 2022

Study information

• Verified date: April 2021
• Source: Integrative Skin Science and Research
• Contact: Raja K Sivamani, MD
• Phone: 916-524-1216
• Email: raja.sivamani[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Microbiome

Intervention

Dietary Supplement:
• Probiotic
Bacillus indicus

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Microbiome labs

Country where clinical trial is conducted

United States, 

Outcome

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