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Could donor bacteria beat recurring vaginal infections?

NCT ID NCT04517487

Disease control Sponsor: Hadassah Medical Organization Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether transferring vaginal fluid from healthy donors can help people with recurrent bacterial vaginosis (BV) that doesn't respond well to antibiotics. Participants receive either the donor fluid or a placebo (saline) to see if the transplant restores a healthier vaginal microbiome and eases symptoms like discharge and odor. The study includes 30 adults aged 18-50 with a history of frequent BV episodes.

What this could mean

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

Active substance
Vaginal fluid from healthy donors, introduced into the vagina to replace disease-associated bacteria
What this could lead to
If it works, this could offer a new option for people with stubborn, recurring bacterial vaginosis that antibiotics don't fix.
What could go wrong
This is an early-stage trial with only 30 participants, so results may not apply broadly. Risks include infection or the transplant not taking hold.

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

30 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Dec 2026

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: * Ages 18-50 * Recurrent BV, defined as ≥4 symptomatic episodes of BV during the last year, who require maintenance antibiotic treatment (twice weekly) in order to remain symptom-free, or if they experienced recurrence of BV in ≤ 2 months following antibiotic treatment, with a documented history of recurrent BV in the last year. * Patients are otherwise healthy. * Contraception use Exclusion Criteria: * Pregnancy or a planned pregnancy in the upcoming year * Infection with HIV. * Immunodeficiency status.

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Conditions

The condition(s) this trial relates to.

bacterial vaginosis

As listed by the trial registrant

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

Bacterial vaginoses

Contacts and locations

Locations

  • Hadassah Medical Center

    Jerusalem, 9765422, Israel

More trials for these conditions

Other studies related to the condition(s) this trial covers.