Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris
NCT ID: NCT04596748
Last Updated: 2020-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
70 participants
INTERVENTIONAL
2020-05-11
2021-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Participants will be taking a placebo supplement that they will be taking by mouth once per day.
Placebo
Placebo caps
Probiotic
Participants will be taking a probiotic supplement that they will be taking by mouth once per day.
Probiotic
Bacillus Subtilis, Bacillus Clausii, Bacillus Coagulans, Bacillus Indicus HU36, MCC 102
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Probiotic
Bacillus Subtilis, Bacillus Clausii, Bacillus Coagulans, Bacillus Indicus HU36, MCC 102
Placebo
Placebo caps
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
13 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Microbiome labs
UNKNOWN
Integrative Skin Science and Research
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Raja Sivamani
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Integrative Skin Science and Research
Sacramento, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Raja K Sivamani, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISSR-Prob-GutSkin
Identifier Type: -
Identifier Source: org_study_id