MetabolismNCT04281407
Impact of Probiotics on Drug, Vitamin, and Hormone Metabolism
A study testing Visbiome in people with Metabolism, run by University of Washington at 1 site in United States.
Trial summary
This is an open-label, fixed sequence study of the effect of probiotics supplementation on drug, vitamin, and hormone metabolism. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism
- What is being tested?
- Visbiome
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2020to 31 Aug 2020
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be 18 to 40 years old.
- Biological male participants only with no preference to ethnicity. Women are excluded as one of the aims is to determine the impact of probiotics supplementation on testosterone metabolism. As testosterone and metabolite levels are higher in men than in women, men will be recruited to have an increased ability to detect a difference.
- Have a body mass index between 25 and 3218.5 and 27 kg/m2.
- Be currently in good health without a self-reported history of liver, kidney, gastrointestinal or heart disease, and within the normal range or up to 15% of the upper end of the reference range on the Comprehensive and Hepatic Panel.
- Participants must agree to take 2 capsules of Visbiome, a probiotics supplement provided by the study coordinators, twice a day (morning and evening) from Study Day 2 to 29.
- Participants must agree not to take any prescription drugs for the entire duration of the study. This list includes, but is not restricted to, azole antifungal agents, macrolide antibiotics, anti-seizure medications, antihypertensive agents, cholesterol lowering agents, retinoids, corticosteroids, or immunosuppressant medications for the duration of the study.
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- Participants must be willing to avoid ingesting grapefruit, grapefruit juice or other grapefruit juice containing products during the study.
- If an over-the-counter medication is needed, the participant should contact the study coordinator for verification and upon approval, the OTCs can be taken but should not be used 24 hours before each study visit and during the study visits.
- Willing to fast overnight before the pharmacokinetic study days.
- Willing to abstain from alcohol-containing beverages 24 hours before and during the study visits.
Who cannot join
- Milk allergy or lactose intolerance.
- Currently using prescription medications. Participants may participate in the study following a 2-week washout after discontinuing any prescription medication upon approval of the study team.
- Current cigarette smoker.
- Individuals with systemic disorders affecting the immune system (e.g., HIV, connective tissue disorders, cancers, etc.)
- Self-reported history of liver, kidney, gastrointestinal (e.g., Ulcerative Colitis or Crohn's Disease, intestinal stricture, stenosis, obstruction, fistula, abscess, or ileostomy) or heart disease.
- Abnormal liver or kidney function tests based on the Comprehensive and Hepatic Panel (below the lower end or greater than 15% of the upper end of the reference range).
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- Known or suspected history of alcohol or drug abuse.
- Allergic to midazolam, triazolam, diazepam, or lorazepam.
- Recent ingestion (<1 week) of any medication known to be metabolized by CYP3A4 or alter CYP3A activity.
- Unable to give informed consent.
- Participated in another clinical trial or study within 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Yvonne Lin, PhD, 206-616-8728, yvonlin@uw.edu
About this study
This is an open-label, fixed sequence study of the effect of probiotics supplementation on drug, vitamin, and hormone metabolism.
Read the detailed description
The investigators hypothesize that probiotic treatment (Visbiome) will alter the activities of major classes of drug metabolizing enzymes. Twelve healthy male subjects will participate in a pharmacokinetic study prior to and following supplementation with Visbiome probiotics for 28 days.
The investigators will determine the pharmacokinetics of oral and intravenous midazolam [metabolized by cytochrome P450 3A enzymes, uridine 5'-diphospho-glucuronosyltransferases (UGTs) and sulfotransferase (SULTs)] and acetaminophen (metabolized by UGTs and SULTs), and the circulating concentrations of endogenous compounds (i.e., testosterone and vitamin D metabolites) prior to and following supplementation with Visbiome probiotics for 28 days. In addition, the investigators will compare the fecal microbiota composition and plasma lipidomic and metabolomics profiles to assess the impact of Visbiome supplementation.
- Conditions
- Metabolism
- Being tested
- Visbiome
- Keywords
- drug metabolism, CYP3A, UGT, SULT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisbiomeDietary supplement
2 capsules of Visbiome, a probiotics supplement, twice a day (morning and evening) for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotics treatment on midazolam and acetaminophen metabolism | Experimental | Experimental:
Day 1: midazolam (2 mg oral) + acetaminophen (500 mg oral) + midazolam (1 mg IV) Days 1-28: Visbiome (2 capsules) administered BID Day 11: midazolam (2 mg oral) + acetaminophen (500 mg oral) + midazolam (1 mg IV) Receives: Dietary Supplement: Visbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral midazolam peak concentration (Cmax)
Following 2 mg midazolam syrup given orally at time = 0
Measured: 0 to 3 hours on Days 1 and 29
IV midazolam peak concentration (Cmax)
Following 1 mg midazolam given IV at time = 3 hrs
Measured: 3 to 12 hours on Days 1 and 29
Overall midazolam area under the curve (AUC)
Following 2 mg midazolam syrup given orally and 1 mg midazolam given IV
Measured: 0 to 12 hours on Days 1 and 29
Overall 1'-hydroxymidazolam area under the curve (AUC)
Following 2 mg midazolam syrup given orally and 1 mg midazolam given IV
Measured: 0 to 12 hours on Days 1 and 29
Acetaminophen peak concentration (Cmax)
500 mg acetaminophen given orally
Measured: 0 to 12 hours on Days 1 and 29
Acetaminophen area under the curve (AUC)
500 mg acetaminophen given orally at time = 0
Measured: 0 to 12 hours on Days 1 and 29
Acetaminophen-glucuronide area under the curve (AUC)
500 mg acetaminophen given orally at time = 0
Measured: 0 to 12 hours on Days 1 and 29
Acetaminophen-sulfate area under the curve (AUC)
500 mg acetaminophen given orally at time = 0
Measured: 0 to 12 hours on Days 1 and 29
Secondary outcomes (5)
Midazolam terminal half-life
Following 2 mg midazolam syrup given orally and 1 mg midazolam given IV
Measured: 0 to 12 hours on Days 1 and 29
Acetaminophen terminal half-life
500 mg acetaminophen given orally at time = 0
Measured: 0 to 12 hours on Days 1 and 29
Urinary excretion of 1'-hydroxymidazolam
Amount of 1'-hydroxymidazolam recovered in urine
Measured: 0 to 12 hours on Days 1 and 29
Urinary excretion of acetaminophen-glucuronide
Amount of acetaminophen-glucuronide recovered in urine
Measured: 0 to 12 hours on Days 1 and 29
Urinary excretion of acetaminophen-sulfate
Amount of acetaminophen-sulfate recovered in urine
Measured: 0 to 12 hours on Days 1 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start3 Jan 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm prospective study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvonne Lin, University of Washington
- Investigators
- Yvonne Lin, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281407
- Sponsor's protocol ID
- STUDY00007095
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Probiotics on Drug, Vitamin, and Hormone Metabolism
- ClinicalTrials.gov ID
- NCT04281407
- Acronym / sponsor ID
- STUDY00007095
- Conditions
- Metabolism
- Keywords
- drug metabolism, CYP3A, UGT, SULT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 24 Feb 2020 (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.
This is an open-label, fixed sequence study of the effect of probiotics supplementation on drug, vitamin, and hormone metabolism.
Detailed description
The investigators hypothesize that probiotic treatment (Visbiome) will alter the activities of major classes of drug metabolizing enzymes. Twelve healthy male subjects will participate in a pharmacokinetic study prior to and following supplementation with Visbiome probiotics for 28 days.
The investigators will determine the pharmacokinetics of oral and intravenous midazolam [metabolized by cytochrome P450 3A enzymes, uridine 5'-diphospho-glucuronosyltransferases (UGTs) and sulfotransferase (SULTs)] and acetaminophen (metabolized by UGTs and SULTs), and the circulating concentrations of endogenous compounds (i.e., testosterone and vitamin D metabolites) prior to and following supplementation with Visbiome probiotics for 28 days. In addition, the investigators will compare the fecal microbiota composition and plasma lipidomic and metabolomics profiles to assess the impact of Visbiome supplementation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm prospective study
| Arm | Type | Receives |
|---|---|---|
| Probiotics treatment on midazolam and acetaminophen metabolism | Experimental | Dietary Supplement: VisbiomeExperimental: Day 1: midazolam (2 mg oral) + acetaminophen (500 mg oral) + midazolam (1 mg IV) Days 1-28: Visbiome (2 capsules) administered BID Day 11: midazolam (2 mg oral) + acetaminophen (500 mg oral) + midazolam (1 mg IV) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Be 18 to 40 years old.
- Biological male participants only with no preference to ethnicity. Women are excluded as one of the aims is to determine the impact of probiotics supplementation on testosterone metabolism. As testosterone and metabolite levels are higher in men than in women, men will be recruited to have an increased ability to detect a difference.
- Have a body mass index between 25 and 3218.5 and 27 kg/m2.
- Be currently in good health without a self-reported history of liver, kidney, gastrointestinal or heart disease, and within the normal range or up to 15% of the upper end of the reference range on the Comprehensive and Hepatic Panel.
- Participants must agree to take 2 capsules of Visbiome, a probiotics supplement provided by the study coordinators, twice a day (morning and evening) from Study Day 2 to 29.
Key exclusion criteria (11 listed)
- Milk allergy or lactose intolerance.
- Currently using prescription medications. Participants may participate in the study following a 2-week washout after discontinuing any prescription medication upon approval of the study team.
- Current cigarette smoker.
- Individuals with systemic disorders affecting the immune system (e.g., HIV, connective tissue disorders, cancers, etc.)
- Self-reported history of liver, kidney, gastrointestinal (e.g., Ulcerative Colitis or Crohn's Disease, intestinal stricture, stenosis, obstruction, fistula, abscess, or ileostomy) or heart disease.
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 |
|---|---|---|
| Visbiome2 capsules of Visbiome, a probiotics supplement, twice a day (morning and evening) for 28 days | Dietary supplement | Probiotics treatment on midazolam and acetaminophen metabolism |
Primary outcome
Oral midazolam peak concentration (Cmax)
Time frame: 0 to 3 hours on Days 1 and 29
Following 2 mg midazolam syrup given orally at time = 0
IV midazolam peak concentration (Cmax)
Time frame: 3 to 12 hours on Days 1 and 29
Following 1 mg midazolam given IV at time = 3 hrs
Overall midazolam area under the curve (AUC)
Time frame: 0 to 12 hours on Days 1 and 29
Following 2 mg midazolam syrup given orally and 1 mg midazolam given IV
Overall 1'-hydroxymidazolam area under the curve (AUC)
Time frame: 0 to 12 hours on Days 1 and 29
Following 2 mg midazolam syrup given orally and 1 mg midazolam given IV
Acetaminophen peak concentration (Cmax)
Time frame: 0 to 12 hours on Days 1 and 29
500 mg acetaminophen given orally
Acetaminophen area under the curve (AUC)
Time frame: 0 to 12 hours on Days 1 and 29
500 mg acetaminophen given orally at time = 0
Acetaminophen-glucuronide area under the curve (AUC)
Time frame: 0 to 12 hours on Days 1 and 29
500 mg acetaminophen given orally at time = 0
Acetaminophen-sulfate area under the curve (AUC)
Time frame: 0 to 12 hours on Days 1 and 29
500 mg acetaminophen given orally at time = 0
5 secondary outcomes
Midazolam terminal half-life
Time frame: 0 to 12 hours on Days 1 and 29
Acetaminophen terminal half-life
Time frame: 0 to 12 hours on Days 1 and 29
Urinary excretion of 1'-hydroxymidazolam
Time frame: 0 to 12 hours on Days 1 and 29
Urinary excretion of acetaminophen-glucuronide
Time frame: 0 to 12 hours on Days 1 and 29
Urinary excretion of acetaminophen-sulfate
Time frame: 0 to 12 hours on Days 1 and 29
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
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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.
Yvonne Lin, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visbiome in people with Metabolism, run by University of Washington 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 10 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: status not confirmed, as of the sponsor's last update on 24 Feb 2020. 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 Yvonne Lin, PhD (206-616-8728, yvonlin@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral midazolam peak concentration (Cmax) (time frame: 0 to 3 hours on Days 1 and 29). The study lists 8 primary outcomes in all. 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 24 Feb 2020.