Human MicrobiomeNCT04841694
Oral Probiotics on the Shift in Gut Microbiome and Skin Carotenoid Levels
A study testing Probiotic in people with Human Microbiome, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
The purpose of this study is to determine how probiotics affects circulating carotenoid levels. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to Mar 2022
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 40+
- Must be willing to comply with all protocol requirements
- Must be willing to have flash photo facial images taken with the imaging systems
- Fitzpatrick skin type II, III, or IV
Who cannot join
- Any systemic or antibiotics (injected or oral) within 6 months of starting study
- Any topical antibiotic or Vitamin A within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or vitamin A ingredient.
- Any oral probiotic or prebiotic supplementation within past 1 month at the discretion of the investigator.
- Limit total fruit and vegetable intake to 2.5 servings (1 serving=1 cup) per day of high carotenoid foods. High carotenoid foods include spinach, summer squash, carrots, citrus fruits, celery, kale, tomatoes, and cantaloupe
- Subjects must have no history of malignancy or cancer (excluding skin cancer unless there is a history of metastasis) 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
Show all 21Show fewer
- Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating.
- Is participating in a concurrent intervention based clinical research study
- Those with BMI higher than 35 kg/m²
- 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.
- Is participating in or has participated in a intervention based facial study at this or any other facility in the past 2 weeks. Participation in survey-based studies are approved at the discretion of the investigator.
- Has a skin disease on face 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.
- Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, sun tanning, or artificial tanning.
- Known allergy or irritation to the supplement utilized in the study
- Persons unwilling to avoid sun exposure to the inner forearm
- Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
- Cutaneous photosensitivity at wavelengths of 400-450 nm
- Porphyria or known allergies to porphyrins
- Prisoners
- Adults unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research
Sacramento, California, 95815
Raja K Sivamani, MD, 916-524-1216, raja.sivamani@integrativeskinresearch.com
About this study
Official title: Prospective Randomized Double-Blind Placebo Controlled Study of Oral Probiotics on the Shift of Gut Microbiome and Skin Carotenoid Levels
The purpose of this study is to determine how probiotics affects circulating carotenoid levels.
Read the detailed description
Certain probiotic strains are rich in the production of carotenoids. This study will evaluate if probiotic supplementation with a carotenoid rich strain will augment circulating carotenoids.
- Conditions
- Human Microbiome
- Being tested
- Probiotic
- Keywords
- gut microbiome, dermatology, skin, carotenoids, probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Bacillus indicus
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants will be taking a probiotic supplement that they will be taking by mouth once per day Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotenoid Levels
Change in skin carotenoid level and blood carotenoid level with supplementation
Measured: 5 weeks
Secondary outcomes (10)
Gut Microbiome Changes
Shift in gut microbiome diversity
Measured: Week 5
Assessment of GI related gas and constipation
self assessment using digestive health questionnaire
Measured: Week 5
Assessment of GI related gas and constipation
self assessment using digestive health questionnaire
Measured: Week 6
Shift in facial redness- image based
BTBP Clarity Mini 3D camera
Measured: Week 5
Shift in facial redness- image based
BTBP Clarity Mini 3D camera
Measured: Week 6
Shift in facial pigmentation - image based
BTBP Clarity Mini 3D camera
Measured: Week 5
Shift in facial pigmentation - image based
BTBP Clarity Mini 3D camera
Measured: Week 6
Protection against blue light exposure induced change in skin color
Change in skin color measured by a skin colorimeter
Measured: Weeks 5
Protection against blue light exposure induced change in skin color
Change in skin color measured by a skin colorimeter
Measured: Weeks 6
Carotenoid Levels
Change in skin carotenoid level and blood carotenoid level with supplementation
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Jun 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MicrobiomeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Microbiome labs
- Responsible party
- Principal investigator, Raja Sivamani, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841694
- Sponsor's protocol ID
- PROB-CAROT
- Status last verified
- Apr 2021
- First submitted
- 5 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double-Blind Placebo Controlled Study of Oral Probiotics on the Shift of Gut Microbiome and Skin Carotenoid Levels
- ClinicalTrials.gov ID
- NCT04841694
- Acronym / sponsor ID
- PROB-CAROT
- Conditions
- Human Microbiome
- Keywords
- gut microbiome, dermatology, skin, carotenoids, probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Microbiome labs
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 12 Apr 2021 (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 determine how probiotics affects circulating carotenoid levels.
Detailed description
Certain probiotic strains are rich in the production of carotenoids. This study will evaluate if probiotic supplementation with a carotenoid rich strain will augment circulating carotenoids.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticParticipants will be taking a probiotic supplement that they will be taking by mouth once per day |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 40+
- Must be willing to comply with all protocol requirements
- Must be willing to have flash photo facial images taken with the imaging systems
- Fitzpatrick skin type II, III, or IV
Key exclusion criteria (21 listed)
- Any systemic or antibiotics (injected or oral) within 6 months of starting study
- Any topical antibiotic or Vitamin A within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or vitamin A ingredient.
- Any oral probiotic or prebiotic supplementation within past 1 month at the discretion of the investigator.
- Limit total fruit and vegetable intake to 2.5 servings (1 serving=1 cup) per day of high carotenoid foods. High carotenoid foods include spinach, summer squash, carrots, citrus fruits, celery, kale, tomatoes, and cantaloupe
- Subjects must have no history of malignancy or cancer (excluding skin cancer unless there is a history of metastasis) 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)
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 |
|---|---|---|
| ProbioticBacillus indicus | Dietary supplement | Probiotic |
Primary outcome
Carotenoid Levels
Time frame: 5 weeks
Change in skin carotenoid level and blood carotenoid level with supplementation
10 secondary outcomes
Gut Microbiome Changes
Time frame: Week 5
Assessment of GI related gas and constipation
Time frame: Week 5
Assessment of GI related gas and constipation
Time frame: Week 6
Shift in facial redness- image based
Time frame: Week 5
Shift in facial redness- image based
Time frame: Week 6
Shift in facial pigmentation - image based
Time frame: Week 5
Shift in facial pigmentation - image based
Time frame: Week 6
Protection against blue light exposure induced change in skin color
Time frame: Weeks 5
Protection against blue light exposure induced change in skin color
Time frame: Weeks 6
Carotenoid Levels
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
Related trials for Human Microbiome
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
ARDS, Human
Recruiting
Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans
Physical Abilities, FMT
Active, not recruitingObservational study
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Dysbiosis, Clostridium Difficile
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.
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 in people with Human Microbiome, 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 4 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 3 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raja K Sivamani, MD (916-524-1216, raja.sivamani@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotenoid Levels (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2021.