Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

September 23, 2026 updated by: Ahinoam Lev-Sagie, Hadassah Medical Organization

Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial

Vaginal Microbiome Transplantation (VMT) may be beneficial in treating the most severe cases of recurrent and antibiotics-nonresponsive cases of BV.

We completed a preliminary study in which we treated patients with recurrent and antibiotics-non-responsive, intractable BV, with VMT from healthy donors [Lev-Sagie, Nature Medicine 2019]. Four VMT recipients in this preliminary study featured a significant improvement of both clinical symptoms and dysbiotic vaginal microbiome composition and function, which persisted over a long follow-up period, while one recipient featured a partial remission.

The proposed study is designed as a placebo, randomized controlled trial, and is aimed to further assess whether VMT may serve as a viable option in symptomatic, intractable BV. In the suggested study, we compare transplantation of: 1) vaginal fluid from healthy donors (VMT), and 2) saline and glycerol (placebo).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Women diagnosed with symptomatic, recurrent BV, will be recruited. After assessment of inclusion and exclusion criteria and patient's consent to participate, patients will be assigned to receive transplantation of either VMT or a placebo. Patients will be blinded to the therapy given.

Following VMT, patients will be examined every 2 weeks for the first month, and then once every month, for additional 11 months after VMT. In case of BV recurrence, repeated transplantations will be done after antibiotics. Repeated VMTs can be done to a maximum of 6 sessions, before the procedure will be considered a failure.

Placebo recipients will be examined every 2 weeks for the first month, and then once every month for additional 3 months after placebo (total of 4 months). Patients may have up to 3 repeated placebo transplantations during the 4 months. At the 4 months post placebo timepoint, in case they are still symptomatic and fulfill inclusion criteria, patients who initially received placebo will be unblinded and offered a VMT. After VMT, they will be further followed for additional 12 months (every two weeks for the first month and then once a month for additional 11 months).

In each frontal appointment:

  1. Patients will be questioned regarding symptoms (discharge and odor) , adverse events (related and not related to the study), and compliance with the protocol.
  2. Will undergo examination which will include vaginal inspection, pH measurement, whiff test and microscopy.
  3. Samples will be taken.

During the follow-up phase, women who are clinically stable and asymptomatic will be given the option to collect a monthly vaginal sample at home, store it in their home freezer, and bring the collected samples to the clinic at three-month intervals when they arrive to their examination visit. These women will be contacted monthly and will be asked about their symptoms. If they report any change in their condition or recurrence of symptoms, they will be asked to attend the clinic for an examination.

In order to prevent transfer of pathogens, sperm, or antibiotic-resistant commensals we will establish a "vaginal fluid bank" in which samples from suitable donors will be kept for future use:

  • Donors will be screened using a questionnaire addressing risk factors for potentially transmissible infections, undergo screening for cervico-vaginal infections, cervical cytology screening, and serology analysis for transmittable infections.
  • The collected samples for VMT will be examined for bacteria,viruses and sperm.
  • Each sample will be sequenced to verify its composition (L. crisptus dominance).
  • Three months after collection of a sample, donors will undergo repeated serologic screening, to verify for the absence of sero-conversion prior to VMT.

In addition to the main cohort, we will conduct additional observational study;To assess the antimicrobial effects of lactobacilli on pathogenic bacteria, we will use 100 fresh samples from patients with BV or healthy controls. 100ul of These samples will be cultured to evaluate the influence of three antimicrobial molecules secreted by lactobacilli on both pathogenic bacteria and beneficial Lactobacilli in the vaginal microbiome. As a control, we will use lactic acid or boric acid. Samples will be analysed for the microbiome composition before culturting, after over-night culturing and after treatment with the antimicrobial molecules.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 9765422
        • Hadassah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VMT recipients

vaginal microbiome transplant from healthy donors

Before transplantation, patients will be treated with intravaginal antibiotics. A frozen specimen will be thawed at room temperature and will be placed in the patient's vagina.

Following VMT, patients will be evaluated every 14 days for the first month, then every month for additional 11 months.
Biological: Vaginal Microbiome Transplantation (VMT)

Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome
Placebo Comparator: Placebo

Saline with glycerol will be used as placebo.

Before transplantation, patients will be treated with intravaginal antibiotic. Following Placebo, patients will be evaluated every 14 days for the first month, then every month for additional 3 months (total of 4 months) After 4 months, patients who initially received placebo will be offered a VMT in case they are still symptomatic and fulfill inclusion criteria, in an open-label phase.
Other: Placebo

saline mixed with glycerol (10-20% total concentration).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical parameters- patient's complains
Time Frame: Interim analysis at 4 months from initial intervention, and final analysis at 12 months.

participants report disappearance of discharge and odor.
Interim analysis at 4 months from initial intervention, and final analysis at 12 months.
Laboratory parameters- Amsel criteria
Time Frame: Interim analysis at 4 months from initial intervention, and final analysis at 12 months.

Presence or absence of Amsel criteria (discharge, pH>4.5, positive whiff test and clue cells on microscopy).
Interim analysis at 4 months from initial intervention, and final analysis at 12 months.
Vaginal fluid microscopy
Time Frame: Interim analysis at 4 months from initial intervention, and final analysis at 12 months.

Defined as normal (lactobacilli dominated), BV (coccid-bacillary dominated) or mixed.
Interim analysis at 4 months from initial intervention, and final analysis at 12 months.
Microbiome composition
Time Frame: Interim analysis at 4 months from initial intervention, and final analysis at 12 months.

Characterization of the vaginal microbial community using shotgun analysis or 16S rRNA sequencing.
Interim analysis at 4 months from initial intervention, and final analysis at 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hadassah Medical Organization

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Weizmann Institute of Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahinoam Lev-Sagie, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HMO-19-691

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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