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Could a daily pill improve vaginal health? new study investigates

NCT ID NCT07435350

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

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

21 to 60 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Radicle Science Inc.

    Del Mar, California, 92014-2605, United States

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