Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris

NCT04596748 | Unknown

• 1 other identifier: ISSR-Prob-GutSkin
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how probiotics affect sebum production and gut health in those with acne vulgaris.

Conditions

Acne Vulgaris

Keywords

acne vulgaris; skin; dermatology; acne; microbiome; probiotics

Outcome Measures

Primary Outcomes (3)

• Microbiota Diversity

  Evaluation of alpha diversity

  12 weeks

• Short chain fatty acids

  Blood plasma

  12 weeks

• Blood acetate levels

  Blood plasma

  12 weeks

Secondary Outcomes (11)

• Gut microbiome changes

  4 weeks and 8 weeks

• Change in skin microbiome

  12 weeks

• Safety assessments for GI distress

  4 weeks, 8 weeks, 12 weeks

• Change in sebum excretion rate

  4 weeks, 8 weeks, 12 weeks

• Change in skin hydration

  4,8 and 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

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 Subtilis, Bacillus Clausii, Bacillus Coagulans, Bacillus Indicus HU36, MCC 102

Probiotic

Placebo DIETARY_SUPPLEMENT

Placebo caps

Placebo

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects aged 13-45
• Subjects with acne vulgaris as diagnosed by a board-certified dermatologist,having mild-moderate acne on the face with an IGA score of 2-3 and 10+ inflammatory lesions on face and 15+ total lesions.
• Subjects should experience new acne lesions on a recurrent basis within last 6 months
• Must be willing to comply with all protocol requirements
• Must be willing to have flash photo facial images taken with the imaging systems
• Males must be willing to shave any facial hair

You may not qualify if:

• Any systemic antibiotics used to treat acne (injected or oral)within 6 months of starting study. Any 14-day or shorter course of systemic antibiotics (injected or oral) used to treat conditions other than acne within 1 month of starting study
• Any topical antibiotic or benzoyl peroxide within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or benzoyl peroxide ingredient.
• Any oral probiotic or prebiotic supplementation within past 1 month
• Subjects must have no history of malignancy or cancer 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, or post-menopausal.
• Is participating in a concurrent clinical research study or has participated in acne or other facial study at this or any other facility in the past 4 weeks
• Those with BMI higher than 35kg/m²
• 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 and spironolactone are considered hormone-based therapy.
• 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.
• Use of medications that alter blood lipids, such as statins and anti-hyperlipidemic medications
• Is participating in or has participated in acne or other facial study at this or any other facility in the past 4 weeks. Participation in survey-based studies are approved at the discretion of the investigator.
• Has a skin disease on face, other than acne, 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.
• Severe acne or nodulocystic acne, at the discretion of the investigator

Sponsors & Collaborators

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

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95815, United States

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blind, randomized, placebo-controlled

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 22, 2020
• Study Start: May 11, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)