Acne VulgarisNCT05919810
The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne
A study testing Probiotic and Oral herbal powder supplement in people with Acne Vulgaris and Acneiform Eruptions, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluates how probiotics and dietary supplementation with an herbal powder can shift the gut microbiome in those with non-cystic acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris, Acneiform Eruptions, Skin Diseases
- What is being tested?
- Probiotic and Oral herbal powder supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects 12 years of age until 45 years of age
- The presence of mild to moderate acne based on investigator global assessment.
- Presence of at least 10 inflammatory lesions and at least 5 non-inflammatory lesions
Who cannot join
- The presence of severe acne as noted by the investigator global assessment.
- Those who are unwilling to discontinue oral probiotic-based supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment.
- Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide for 2 weeks prior to enrollment
- Those who are unwilling to keep their facial regimen the same throughout the study
- Individuals who have been on an oral antibiotic for acne within the previous one month.
- Individuals who are pregnant or breastfeeding.
Show all 11Show fewer
- Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study.
- Individuals on oral contraceptive pills or progesterone or estrogen containing therapies
- Use of isotretinoin within the three months prior to enrollment.
- Individuals on finasteride or dutasteride
- Current tobacco smoker or a tobacco smoking history
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research
Sacramento, California, 95819
About this study
The purpose of this study is to evaluates how probiotics and dietary supplementation with an herbal powder can shift the gut microbiome in those with non-cystic acne vulgaris.
Read the detailed description
The investigators hope to evaluate the effects of oral supplements in changing intestinal health and the gut bacteria in patients with non-cystic acne vulgaris.
Acne is a chronic inflammatory condition that is estimated to affect greater than 85% of the population at some point. While antibiotics are typically used for systemic therapy, it can increase the risk for drug-resistant bacteria and shift the gut microbiome in a negative way. On the other hand, probiotics and dietary supplementation have been shown to support the gut microbiome.
In this study, participants will be randomized to either receiving a probiotic or powder supplement.
This means that participants will have an equal chance of receiving either product as half of the participants will be randomized to receive only oral probiotic, and the other half will receive oral supplement powder.
- Being tested
- Probiotic, Oral herbal powder supplement
- Keywords
- microbiome, probiotics, dietary supplementation
- Medical subject headings
- Acne Vulgaris, Acneiform Eruptions, Skin Diseases, Sebaceous Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
Oral probiotic
Oral herbal powder supplementDietary supplement
oral herbal powder
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Daily consumption of probiotic Receives: Other: Probiotic |
| Oral herbal supplement | Experimental | Daily consumption of oral herbal supplement powder Receives: Dietary Supplement: Oral herbal powder supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome composition of short chain fatty acid producing bacteria
Change on the relative abundance of Akkermansia mucinaphila and Facelibacterium pruasntizii
Measured: 8 weeks
Stool acetate levels
Assess the short chain fatty acid stool acetate levels
Measured: 8 weeks
Secondary outcomes (2)
Change in salivary progesterone levels
Progesterone and 17-OH progesterone levels
Measured: 4 weeks
Change in salivary progesterone levels
Progesterone and 17-OH progesterone levels
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start3 Jul 2023
- Primary completion12 Feb 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Codex Labs
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD MS AP, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919810
- Sponsor's protocol ID
- CB_Acne_Supp
- Status last verified
- May 2024
- First submitted
- 16 Jun 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Min M, Afzal N, Maloh J, Dulai AS, Ahmad N, Pinzauti D, Sivamani RK. Prospective Comparative Study of an Oral Synbiotic and a Myoinositol-Based Herbal Supplement in Modifying Hormone Levels and the Gut Microbiome in Non-cystic Acne. Dermatol Ther (Heidelb). 2025 Jun;15(6):1331-1350. doi: 10.1007/s13555-025-01411-4. Epub 2025 Apr 18.
PubMed 40246799
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne
- ClinicalTrials.gov ID
- NCT05919810
- Acronym / sponsor ID
- CB_Acne_Supp
- Keywords
- microbiome, probiotics, dietary supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Codex Labs
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluates how probiotics and dietary supplementation with an herbal powder can shift the gut microbiome in those with non-cystic acne vulgaris.
Detailed description
The investigators hope to evaluate the effects of oral supplements in changing intestinal health and the gut bacteria in patients with non-cystic acne vulgaris.
Acne is a chronic inflammatory condition that is estimated to affect greater than 85% of the population at some point. While antibiotics are typically used for systemic therapy, it can increase the risk for drug-resistant bacteria and shift the gut microbiome in a negative way. On the other hand, probiotics and dietary supplementation have been shown to support the gut microbiome.
In this study, participants will be randomized to either receiving a probiotic or powder supplement.
This means that participants will have an equal chance of receiving either product as half of the participants will be randomized to receive only oral probiotic, and the other half will receive oral supplement powder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Other: ProbioticDaily consumption of probiotic |
| Oral herbal supplement | Experimental | Dietary Supplement: Oral herbal powder supplementDaily consumption of oral herbal supplement powder |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Subjects 12 years of age until 45 years of age
- The presence of mild to moderate acne based on investigator global assessment.
- Presence of at least 10 inflammatory lesions and at least 5 non-inflammatory lesions
Key exclusion criteria (11 listed)
- The presence of severe acne as noted by the investigator global assessment.
- Those who are unwilling to discontinue oral probiotic-based supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment.
- Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide for 2 weeks prior to enrollment
- Those who are unwilling to keep their facial regimen the same throughout the study
- Individuals who have been on an oral antibiotic for acne within the previous one month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticOral probiotic | Other | Probiotic |
| Oral herbal powder supplementoral herbal powder | Dietary supplement | Oral herbal supplement |
Primary outcome
Gut microbiome composition of short chain fatty acid producing bacteria
Time frame: 8 weeks
Change on the relative abundance of Akkermansia mucinaphila and Facelibacterium pruasntizii
Stool acetate levels
Time frame: 8 weeks
Assess the short chain fatty acid stool acetate levels
2 secondary outcomes
Change in salivary progesterone levels
Time frame: 4 weeks
Change in salivary progesterone levels
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Derived from this study: PubMed 40246799Min M, Afzal N, Maloh J, Dulai AS, Ahmad N, Pinzauti D, Sivamani RK. Prospective Comparative Study of an Oral Synbiotic and a Myoinositol-Based Herbal Supplement in Modifying Hormone Levels and the Gut Microbiome in Non-cystic Acne. Dermatol Ther (Heidelb). 2025 Jun;15(6):1331-1350. doi: 10.1007/s13555-025-01411-4. Epub 2025 Apr 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja Sivamani, MD MS AP principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Oral herbal powder supplement in people with Acne Vulgaris and Acneiform Eruptions, run by Integrative Skin Science and Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome composition of short chain fatty acid producing bacteria (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05919810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.