Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris

• ClinicalTrials.gov Identifier: NCT04596748
• Recruitment Status: Recruiting
• First Posted: October 22, 2020
• Last Update Posted: November 24, 2020
• Sponsor: Integrative Skin Science and Research
• Collaborator: Microbiome labs
• Information provided by (Responsible Party): Raja Sivamani, Integrative Skin Science and Research

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Dietary Supplement: Probiotic; Dietary Supplement: Placebo	Not Applicable

Detailed Description:

Probiotics have been shown in previous pilot studies to be helpful in acne and this study aims to examine how the gut microbiome and skin biophysical properties are shifted in those with acne vulgaris. In particular, this study will assess the influence of oral spore based probiotics on the skin sebum production and will assess how probiotics influence the gut microbiome and the blood levels of short chain fatty acids.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double-blind, randomized, placebo-controlled
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Double-Blind Placebo-Controlled Study of Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris
• Actual Study Start Date: May 11, 2020
• Estimated Primary Completion Date: March 2021
• Estimated Study Completion Date: March 2021

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Participants will be taking a placebo supplement that they will be taking by mouth once per day.	Dietary Supplement: Placebo; Placebo caps
Experimental: Probiotic; Participants will be taking a probiotic supplement that they will be taking by mouth once per day.	Dietary Supplement: Probiotic; Bacillus Subtilis, Bacillus Clausii, Bacillus Coagulans, Bacillus Indicus HU36, MCC 102

Outcome Measures

Primary Outcome Measures :

1. Microbiota Diversity [ Time Frame: 12 weeks ]
   Evaluation of alpha diversity
2. Short chain fatty acids [ Time Frame: 12 weeks ]
   Blood plasma
3. Blood acetate levels [ Time Frame: 12 weeks ]
   Blood plasma

Secondary Outcome Measures :

1. Gut microbiome changes [ Time Frame: 4 weeks and 8 weeks ]
   Evaluation of alpha diversity
2. Change in skin microbiome [ Time Frame: 12 weeks ]
   Relative abundance cutibacterium genera
3. Safety assessments for GI distress [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
   Self assessment using Digestive Questionnaire
4. Change in sebum excretion rate [ Time Frame: 4 weeks, 8 weeks, 12 weeks ]
   Sebumeter: 0-150 micrograms/cm^2
5. Change in skin hydration [ Time Frame: 4,8 and 12 weeks ]
   Moisturemeter: 0-150
6. Change in skin pH [ Time Frame: 4,8, and 12 weeks ]
   Use of pH meter
7. Facial redness - Image based [ Time Frame: 4,8,12 weeks ]
   BTBP Clarity Mini 3D camera
8. Facial skin tone - Image based [ Time Frame: 4,8,12 weeks ]
   BTBP Clarity Mini 3D camera
9. Subjective assessment of the skin [ Time Frame: 4,8,12 weeks ]
   Self-assessment through Dermatology Quality of Life questionnaire
10. Safety assessment of acne [ Time Frame: 4, 8, 12 weeks ]
    Evaluation of acne to assess for flares
11. Gut Microbiome Changes [ Time Frame: 4, 8, 12 weeks ]
    Relative abundance of Akkermansia muciniphila

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Use of isotretinoin within the 6 months prior to starting in study.
• Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, or artificial tanning.
• Known allergy or irritation to the supplement or facial products utilized in the study
• Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
• Prisoners
• Adults unable to consent

Contacts and Locations

Contacts

Contact: Raja K Sivamani, MD; 916-524-1216; raja.sivamani@integrativeskinresearch.com

Locations

United States, California

Integrative Skin Science and Research; Recruiting

Sacramento, California, United States, 95815

Contact: Raja K Sivamani, MD 916-524-1216 raja.sivamani@integrativeskinresearch.com

Sponsors and Collaborators

Integrative Skin Science and Research

Microbiome labs

More Information

• Responsible Party: Raja Sivamani, Principal Investigator, Integrative Skin Science and Research
• ClinicalTrials.gov Identifier: NCT04596748
• Other Study ID Numbers: ISSR-Prob-GutSkin
• First Posted: October 22, 2020
• Last Update Posted: November 24, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Raja Sivamani, Integrative Skin Science and Research:

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

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases