Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

Prospective Randomized Double-Blind Placebo-Controlled Study of Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04596748
• Other study ID #: ISSR-Prob-GutSkin
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2020
• Est. completion date: March 2021

Study information

• Verified date: November 2020
• 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 affect sebum production and gut health in those with acne vulgaris.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Dietary Supplement:
• Probiotic
Bacillus Subtilis, Bacillus Clausii, Bacillus Coagulans, Bacillus Indicus HU36, MCC 102
• Placebo
Placebo caps

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	Microbiota Diversity	Evaluation of alpha diversity	12 weeks
Primary	Short chain fatty acids	Blood plasma	12 weeks
Primary	Blood acetate levels	Blood plasma	12 weeks
Secondary	Gut microbiome changes	Evaluation of alpha diversity	4 weeks and 8 weeks
Secondary	Change in skin microbiome	Relative abundance cutibacterium genera	12 weeks
Secondary	Safety assessments for GI distress	Self assessment using Digestive Questionnaire	4 weeks, 8 weeks, 12 weeks
Secondary	Change in sebum excretion rate	Sebumeter: 0-150 micrograms/cm^2	4 weeks, 8 weeks, 12 weeks
Secondary	Change in skin hydration	Moisturemeter: 0-150	4,8 and 12 weeks
Secondary	Change in skin pH	Use of pH meter	4,8, and 12 weeks
Secondary	Facial redness - Image based	BTBP Clarity Mini 3D camera	4,8,12 weeks
Secondary	Facial skin tone - Image based	BTBP Clarity Mini 3D camera	4,8,12 weeks
Secondary	Subjective assessment of the skin	Self-assessment through Dermatology Quality of Life questionnaire	4,8,12 weeks
Secondary	Safety assessment of acne	Evaluation of acne to assess for flares	4, 8, 12 weeks
Secondary	Gut Microbiome Changes	Relative abundance of Akkermansia muciniphila	4, 8, 12 weeks