Bacterial VaginosesPhase 1/2NCT04517487
Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis
A Phase 1/2 study testing Vaginal Microbiome Transplantation (VMT) in people with Bacterial Vaginoses, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Bacterial Vaginoses
- What is being tested?
- Vaginal Microbiome Transplantation (VMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Aug 2020to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or a planned pregnancy in the upcoming year
- Infection with HIV.
- Immunodeficiency status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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:
- Patients will be questioned regarding symptoms (discharge and odor) , adverse events (related and not related to the study), and compliance with the protocol.
- Will undergo examination which will include vaginal inspection, pH measurement, whiff test and microscopy.
- 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.
- Conditions
- Bacterial Vaginoses
- Being tested
- Vaginal Microbiome Transplantation (VMT), Placebo
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Microbiome Transplantation (VMT)Biological
Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome
PlaceboOther
saline mixed with glycerol (10-20% total concentration).
| Study group | Role | What they receive |
|---|---|---|
| VMT recipients | Experimental | 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. Receives: Biological: Vaginal Microbiome Transplantation (VMT) |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical parameters- patient's complains
participants report disappearance of discharge and odor.
Measured: Interim analysis at 4 months from initial intervention, and final analysis at 12 months.
Laboratory parameters- Amsel criteria
Presence or absence of Amsel criteria (discharge, pH>4.5, positive whiff test and clue cells on microscopy).
Measured: Interim analysis at 4 months from initial intervention, and final analysis at 12 months.
Vaginal fluid microscopy
Defined as normal (lactobacilli dominated), BV (coccid-bacillary dominated) or mixed.
Measured: Interim analysis at 4 months from initial intervention, and final analysis at 12 months.
Microbiome composition
Characterization of the vaginal microbial community using shotgun analysis or 16S rRNA sequencing.
Measured: Interim analysis at 4 months from initial intervention, and final analysis at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start20 Aug 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Principal investigator, Ahinoam Lev-Sagie, Hadassah Medical Organization
- Investigators
- Ahinoam Lev-Sagie, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517487
- Sponsor's protocol ID
- HMO-19-691
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2020
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lev-Sagie A, Goldman-Wohl D, Cohen Y, Dori-Bachash M, Leshem A, Mor U, Strahilevitz J, Moses AE, Shapiro H, Yagel S, Elinav E. Vaginal microbiome transplantation in women with intractable bacterial vaginosis. Nat Med. 2019 Oct;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6. Epub 2019 Oct 7.
PubMed 31591599
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04517487
- Acronym / sponsor ID
- HMO-19-691
- Conditions
- Bacterial Vaginoses
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Weizmann Institute of Science
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- Patients will be questioned regarding symptoms (discharge and odor) , adverse events (related and not related to the study), and compliance with the protocol.
- Will undergo examination which will include vaginal inspection, pH measurement, whiff test and microscopy.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VMT recipients | Experimental | Biological: Vaginal Microbiome Transplantation (VMT)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. |
| Placebo | Placebo comparator | Other: PlaceboSaline 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy or a planned pregnancy in the upcoming year
- Infection with HIV.
- Immunodeficiency status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Microbiome Transplantation (VMT)Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome | Biological | VMT recipients |
| Placebosaline mixed with glycerol (10-20% total concentration). | Other | Placebo |
Primary outcome
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.
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).
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 31591599Lev-Sagie A, Goldman-Wohl D, Cohen Y, Dori-Bachash M, Leshem A, Mor U, Strahilevitz J, Moses AE, Shapiro H, Yagel S, Elinav E. Vaginal microbiome transplantation in women with intractable bacterial vaginosis. Nat Med. 2019 Oct;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6. Epub 2019 Oct 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahinoam Lev-Sagie principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vaginal Microbiome Transplantation (VMT) in people with Bacterial Vaginoses, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical parameters- patient's complains (time frame: Interim analysis at 4 months from initial intervention, and final analysis at 12 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04517487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.