Could a daily pill improve vaginal health? new study investigates
NCT ID NCT07435350
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a new synbiotic (probiotic plus prebiotic) supplement taken daily for two weeks can improve vaginal health. Two hundred healthy women will be randomly assigned to receive either the active supplement or a placebo. Researchers will check if the probiotic strains reach the vagina and how they affect the vaginal microbiome.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- synbiotic oral supplement (probiotic strains VV-01 plus prebiotic)
- What this could lead to
- If it works, this could point toward a simple daily supplement to support vaginal health and balance the microbiome.
- What could go wrong
- This is an early-stage trial with only 200 participants over 2 weeks, so results may not apply broadly. The supplement may not show meaningful benefits over placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 60 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 (\<4 weeks prior to enrollment) of any other probiotic, prebiotic or synbiotic-containing products * Note: Individuals who undergo a washout of 4-weeks prior to enrollment and are willing to abstain from consuming such products during the study are permitted. Food-based probiotics, prebiotics, and synbiotics are permitted (e.g., kimchi, yoghurt, kefir, kombucha) * Pregnant, breastfeeding, or actively trying to conceive during the study period. * Allergy to any ingredients in the investigational or placebo product. * Receiving chronic oral steroid therapy (excluding those for skin, eyes, nose, or inhaled) or have received such treatment within 4 weeks of enrollment * Surgery, immunotherapy, chemotherapy, radiation, or biological cancer therapy within 4 weeks of enrollment and/or planned during the next 2 weeks * Diagnosed and active serious medical condition requiring current treatment (e.g., cancer; autoimmune diseases \[lupus, rheumatoid arthritis, Crohn's disease\]; serious cardiac, liver, endocrine (insulin-dependent diabetes and/or on SGLT2 inhibitors such as Jardiance®/Empagliflozin, Farxiga®/Dapagliflozin) or kidney disease; psychiatric conditions / substance use disorders; chronic infections \[HIV, Hepatitis B/C\], any condition which in the investigator's opinion may jeopardize the individual's safety or interfere with the ability to comply with the study * Participation in another clinical trial within 90 days of screening * International travel during the study period
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Radicle Science Inc.
Del Mar, California, 92014-2605, United States
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