A Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health

A randomized, placebo-controlled trial to assess the Pharmacokinetics and Pharmacodynamics of a novel synbiotic dietary supplement for vaginal health.

Inclusion criteria Participants must meet all the following criteria: * Healthy women with a vagina 21 - 60 years old at the time of electronic consent * Sex assigned female at birth * Eligible menstrual status: * Pre-menopausal is defined as women in their childbearing years who must have a regular menstrual cycle (consistently average cycle length of 21 to 35 days) Note: Women in their childbearing years who do not have a regular menstrual cycle due to a hormone-based intrauterine device are eligible * Peri-menopausal is defined as women who report irregular periods (differences in menstruation compared with their typical cycle in their 20s), with at least 1 period in the last 12 months AND report mild menopausal symptoms (e.g., vasomotor symptoms such as hot flashes, night sweats) * Post-menopausal is defined as women with an absence of menstrual cycle for the last 12 consecutive months or longer * Willing to ingest an oral capsule during the study and be blinded to product identity (active or placebo) * Willing to self-collect vaginal swabs and pH samples * Willing to abstain from the use of intravaginal products during the study period (e.g., vaginal suppositories, vaginal moisturizers including hyaluronic acid, boric acid suppositories, pH balancing wipes, douching, vaginal creams/gels), as well as lubrication and spermicides * Able to read and comprehend English and provide electronic informed consent * Resides in the United States Exclusion criteria * Active vaginal, pelvic, or urogenital infection (e.g., UTI, BV, yeast infection) * Chronic vulvar and vaginal conditions (e.g., vulvodynia, lichen sclerosis and lichen planus, desquamative inflammatory vaginitis) * Unexplained vaginal bleeding * Use of copper-based intrauterine devices * Note: Hormone-based intrauterine devices are permitted (e.g., Mirena®) * For peri-menopausal and post-menopausal individuals, use of estrogen-based vaginal cream/gel or suppositories * Women who have undergone surgical menopause (e.g., bilateral oophorectomy with or without hysterectomy) * Current or recent use (\< 3 months prior to enrollment) of antibiotics or antifungals, or anticipated use during study period (e.g., perioperative antibiotics for upcoming elective procedures) * Current or recent use (\