Gut MicrobiomeNCT03605108
The Influence of Oral Probiotics on the Microbiome and Lipidome
A study testing Probiotic in people with Gut Microbiome and Skin Microbiome, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to measure oil production of the face, facial properties, and gut bacteria in people being given oral probiotics. Probiotic supplements contain active cultures of bacteria that are thought to be beneficial to human health.The investigators want to find out if probiotics taken by mouth… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Skin Microbiome, Gut Lipidome
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2018to 9 May 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
Who cannot join
- Those on oral antibiotics within a month of initiating the study.
- Subjects must have no history of diabetes, known cardiovascular disease, known immunocompromised condition, malignancy, kidney disease, or chronic steroid use.
- Subjects must have no history or diagnosis of gastrointestinal inflammatory diseases.
- Those with BMI higher than 30 kg/m²
- Those on topical medications to the face such as retinoids or antibiotics who are not willing or medical unable (in the judgement of the investigator) to discontinue use for two weeks prior to the study and for the duration of study participation.
- 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 are considered hormone releasing therapy.
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- Use of medications that alter blood lipids, such as statins and anti-hyperlipidemic medications
- Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
- Pregnant women
- Prisoners
- Adults unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Dermatology
Sacramento, California, 95816
About this study
The purpose of this study is to measure oil production of the face, facial properties, and gut bacteria in people being given oral probiotics. Probiotic supplements contain active cultures of bacteria that are thought to be beneficial to human health.The investigators want to find out if probiotics taken by mouth alter the bacteria in subject's gut and subject's skin oil production compared to a placebo. This is a single blind study and subject may receive a probiotic or a placebo for the first half of the study and a placebo or a probiotic for the second half of the study. Subject will not know what was given to participants.
Read the detailed description
Antibiotics are widely used within dermatology for the treatment of chronic skin conditions such as acne, rosacea, and atopic dermatitis. Previous studies have shown that oral probiotics may be beneficial for skin disesaes such as atopic dermatitis and acne, but a mechanism for how the gut communicates to the skin remains elusive.
The balance between short chain fatty acids and long chain fatty acids has been proposed as one factor in how bacteria in the gut are able to communicate with the rest of the body. Studies in Dr. Sivamani's lab have shown that subjects with acne have a reduced level of short chain fatty acids in their blood when compared to age-matched control (unpublished).
The aim of this study is to understand how oral probiotics may alter the gut microbiome and if they can augment the short chain fatty acids in the blood lipidome. Ultimately, the investigator's goal is to find suitable alternatives for the use of antibiotics in the treatment of chronic skin conditions so that the amount of antibiotics that are in use can be reduced.
- Conditions
- Gut Microbiome, Skin Microbiome, Gut Lipidome, Skin Lipidome, Blood Lipidome
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
- Probiotic fomula per capsule:
- 2 Billion CFUs
- HU36 - 30 mg
- HU58 - 20 mg
- Bacillus clausii -25 mg
- Bacillus coagulans 10B - 35 mg
- Prepro - 22 mg. The prebiotic that is to be used in the proprietary blend is a vegetable grade cellulose.
PlaceboOther
Rice flour only
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | • Probiotic fomula per capsule:
2 Billion CFUs HU36 - 30 mg HU58 - 20 mg Bacillus clausii -25 mg Bacillus coagulans 10B - 35 mg Prepro - 22 mg. The prebiotic that is to be used in the proprietary blend is a vegetable grade cellulose. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Rice flour only Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Lipidome Changes
The primary objective is to assess if probiotics rich in the production of short chain fatty acids can shift the blood lipidome to have a higher level of short chain fatty acids
Measured: 8 weeks +/- 1 week
Secondary outcomes (3)
Gut Microbiome Changes
Specifically the presence of short chain fatty acid producing bacteria
Measured: 8 weeks +/- 1 week
Sebum Production
Sebum production will be measured via Sebumeter device that will calculate sebum in micrograms/centimeter^2
Measured: 8 weeks +/- 1 week
Hydration
Hydration will be measured via Moisturemeter device that will measure hydration in arbitrary units (AU)
Measured: 8 weeks +/- 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start29 Jun 2018
- Primary completion9 May 2019
- Study completion9 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja K. Sivamani, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605108
- Sponsor's protocol ID
- 1242039
- Status last verified
- Jun 2019
- First submitted
- 3 Jul 2018
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Oral Probiotics on the Microbiome and Lipidome
- ClinicalTrials.gov ID
- NCT03605108
- Acronym / sponsor ID
- 1242039
- Conditions
- Gut Microbiome, Skin Microbiome, Gut Lipidome, Skin Lipidome, Blood Lipidome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 30 Jul 2018 (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 measure oil production of the face, facial properties, and gut bacteria in people being given oral probiotics. Probiotic supplements contain active cultures of bacteria that are thought to be beneficial to human health.The investigators want to find out if probiotics taken by mouth alter the bacteria in subject's gut and subject's skin oil production compared to a placebo. This is a single blind study and subject may receive a probiotic or a placebo for the first half of the study and a placebo or a probiotic for the second half of the study. Subject will not know what was given to participants.
Detailed description
Antibiotics are widely used within dermatology for the treatment of chronic skin conditions such as acne, rosacea, and atopic dermatitis. Previous studies have shown that oral probiotics may be beneficial for skin disesaes such as atopic dermatitis and acne, but a mechanism for how the gut communicates to the skin remains elusive.
The balance between short chain fatty acids and long chain fatty acids has been proposed as one factor in how bacteria in the gut are able to communicate with the rest of the body. Studies in Dr. Sivamani's lab have shown that subjects with acne have a reduced level of short chain fatty acids in their blood when compared to age-matched control (unpublished).
The aim of this study is to understand how oral probiotics may alter the gut microbiome and if they can augment the short chain fatty acids in the blood lipidome. Ultimately, the investigator's goal is to find suitable alternatives for the use of antibiotics in the treatment of chronic skin conditions so that the amount of antibiotics that are in use can be reduced.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Probiotic• Probiotic fomula per capsule: 2 Billion CFUs HU36 - 30 mg HU58 - 20 mg Bacillus clausii -25 mg Bacillus coagulans 10B - 35 mg Prepro - 22 mg. The prebiotic that is to be used in the proprietary blend is a vegetable grade cellulose. |
| Placebo | Placebo comparator | Other: PlaceboRice flour only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older
Key exclusion criteria (11 listed)
- Those on oral antibiotics within a month of initiating the study.
- Subjects must have no history of diabetes, known cardiovascular disease, known immunocompromised condition, malignancy, kidney disease, or chronic steroid use.
- Subjects must have no history or diagnosis of gastrointestinal inflammatory diseases.
- Those with BMI higher than 30 kg/m²
- Those on topical medications to the face such as retinoids or antibiotics who are not willing or medical unable (in the judgement of the investigator) to discontinue use for two weeks prior to the study and for the duration of study participation.
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 |
|---|---|---|
| Probiotic• Probiotic fomula per capsule: * 2 Billion CFUs * HU36 - 30 mg * HU58 - 20 mg * Bacillus clausii -25 mg * Bacillus coagulans 10B - 35 mg * Prepro - 22 mg. The prebiotic that is to be used in the proprietary blend is a vegetable grade cellulose. | Dietary supplement | Probiotic |
| PlaceboRice flour only | Other | Placebo |
Primary outcome
Blood Lipidome Changes
Time frame: 8 weeks +/- 1 week
The primary objective is to assess if probiotics rich in the production of short chain fatty acids can shift the blood lipidome to have a higher level of short chain fatty acids
3 secondary outcomes
Gut Microbiome Changes
Time frame: 8 weeks +/- 1 week
Sebum Production
Time frame: 8 weeks +/- 1 week
Hydration
Time frame: 8 weeks +/- 1 week
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 12 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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 K. Sivamani, MD principal investigator
UC Davis
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 Gut Microbiome and Skin Microbiome, run by University of California, Davis 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 1 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 12 Jun 2019. 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. Some participants in this study may receive a placebo. 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?
Blood Lipidome Changes (time frame: 8 weeks +/- 1 week). 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 12 Jun 2019.