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Could a 'Vaginal microbiome Transplant' stop recurring BV?

NCT ID NCT07566754

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether transferring vaginal fluid from healthy donors can help women aged 18-25 with recurrent bacterial vaginosis (BV). Participants first receive standard antibiotics, then the transplant. The goal is to see if this restores a healthy vaginal microbiome and prevents BV from coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vaginal microbiome transplantation (VMT) from healthy donors, plus oral metronidazole
What this could lead to
If it works, this could offer a new way to restore healthy vaginal bacteria and reduce repeat infections for women with recurrent bacterial vaginosis.
What could go wrong
This is a small, early-phase trial (75 people) testing a novel biological treatment. It may not work for everyone, and long-term safety and effectiveness are unknown.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 25 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Premenopausal females between 18 to 25 years of age who are enrolled in the FRESH study * Nugent score ≥ 4 * Confirmation of use of effective contraceptive method by all study recipient participants (referred to as recipients) of child-bearing potential, which includes use of at least one of the following: Hormonal method, such as birth control pills, patches, injections, vaginal rings, or implants; Barrier method, such as a condom or diaphragm used with a spermicide (a foam, cream, or gel that kills sperm); Intrauterine device (IUD) - non-levonorgestrel containing * Ability and willingness to give written informed consent. Exclusion Criteria: * History of clinically significant vaginal, cervical, or uterine disease including but not limited to cancer of the female reproductive tract, prior hysterectomy, high grade cervical dysplasia (CIN III), or diagnosed with cervicovaginal infection (with the exception of bacterial vaginosis or yeast) within the 30 days prior to the procedure * Allergy to metronidazole * Use of investigational therapies or investigational vaccines within 90 days prior to study screening * Has not received the HPV vaccine and is not willing to be vaccinated * Metabolic syndrome, e.g. diabetes, pre-diabetes, glucose intolerance * Use of any immunomodulatory agents within 30 days prior to study enrollment * Participants taking any of the following medications: systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons, or systemic chemotherapy * History of coronary artery disease, myocardial infarction, COPD, chronic renal failure, decompensated cirrhosis, or any other condition that in the opinion of the investigator will compromise ability to participate in the study * Pap smear result of LSIL, HSIL, AGUS * Insertion of levonorgestrel-containing IUD within 90 days prior to study enrollment * Either breastfeeding, pregnant, or trying to conceive within 24 weeks prior to study enrollment; or becomes pregnant during study period * Use of probiotics and prebiotics (supplements and products, oral or vaginal) within 30 days of the study \- NOTE: Oral yogurt with live cultures and fermented foods are allowed. * Routine use of oral antibiotics i.e., daily use for acne, Hiradenitis suppurativa, or regular use for post-coital urinary tract infection prophylaxis within the past 30 days * Taken non-metronidazole antibiotics in last 30 days * Taken metronidazole within the last 2 weeks * BMI \> 40 * Positive for any of the STIs listed below or on treatment for any of them. * Neisseria gonorrhoeae * Chlamydia trachomatis * HIV * Trichomonas vaginalis * Syphilis * Mycoplasma genitalium * Currently employed at, or professionally affiliated with the FRESH clinical research site, UKZN's HIV Pathogenesis Program (HPP), or the Ragon Institute of Mass General Brigham, MIT and Harvard (referred to as "the Ragon/MGH" in this document). * Screens positive for TB by symptomatic questionnaire

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • FRESH Clinic

    Durban, South Africa