Could a 'Microbiome Transplant' stop recurring vaginal infections?

NCT ID NCT04046900

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether transplanting vaginal fluid from healthy donors can restore a healthy bacterial balance in women with recurrent bacterial vaginosis (BV). Participants receive either the transplant or a placebo after antibiotic treatment. The goal is to see if the transplant helps maintain protective Lactobacillus bacteria and prevent 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 transplant (donor vaginal fluid)
What this could lead to
If successful, this approach could offer a new way to prevent recurrent bacterial vaginosis by restoring healthy vaginal bacteria.
What could go wrong
This is an early-phase trial with a small number of participants. The transplant may not take hold, or side effects could occur. Results may not apply to all women.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 62 people

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

Started

Apr 2021

Expected to finish

Jun 2027

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 50 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 women, 18- 50 years old * Abnormal Nugent score: \> 3 * History of recurrent bacterial vaginosis (BV) (3 or more documented episodes in past 12 months) * If participating in sexual activity that could lead to pregnancy, study participants must agree to use an effective contraceptive while actively participating in the protocol. At least one of the following methods MUST be used: * Condoms (male or female), with or without a spermicidal agent * Intrauterine device (IUD) * Hormonal contraceptive (including oral pills, vaginal ring, implant, injection) 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) within the 30 days prior to the procedure. * Allergy to metronidazole * Use of investigational therapies or investigational vaccines within 90 days prior to study entry * Use of any immunomodulatory agents within 30 days prior to study enrollment. Subject taking any of the following medications: systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (e.g. local injection of interferon alpha for treatment of HPV is permitted) 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. * History of abnormal pap smear within 12 months * Insertion of levonorgestrel-containing IUD within 3 months prior to study entry * Either breastfeeding or pregnant within 24 weeks prior to study entry * Use of probiotics and prebiotics (supplements and products, oral or vaginal) within 30 days of the study. (NOTE: Oral yogurt with live cultures is allowed.) * Routine use of oral antibiotics i.e. daily use for acne, Hidradenitis suppurativa, or regular use for post-coital urinary tract infection prophylaxis within the past 30 days. * Taken non-metronidazole antibiotics in last 30 days * BMI \> 40

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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

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  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

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