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Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596748
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : November 24, 2020
Sponsor:
Collaborator:
Microbiome labs
Information provided by (Responsible Party):
Raja Sivamani, Integrative Skin Science and Research

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596748


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

Locations
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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
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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    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases