Eligibility Details:
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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).
- 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.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
