Recurrent Bacterial VaginitisVFTNCT02236429
Vaginal Flora for Treatment of Bacterial Vaginosis
A study testing vaginal flora transplant in people with Recurrent Bacterial Vaginitis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is a high rate of recurrence. Almost half of women successfully treated suffer a recurrence within three months. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Recurrent Bacterial Vaginitis
- What is being tested?
- vaginal flora transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2015to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- recurrent BV (4 or more incidences in the past year)
- recurrence of BV in less than 2 months of antibiotic treatment or need for prophylactic antibiotic
- 3/4 Amsel criteria and Nugent criteria greater or equal to 7
Who cannot join
- pregnancy or planned pregnancy during the study period
- other known diseases
- carriers of Hep B and C
- HIV or syphilis positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis
Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is a high rate of recurrence. Almost half of women successfully treated suffer a recurrence within three months. Complications include risk factors for premature birth, increased transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The investigators proposed study is a cost effective treatment based on returning the normal microbial balance to the vagina. The investigators propose to transfer normal vaginal flora from healthy individuals to women with BV and thus restore normal vaginal flora and cure this disorder.
- Conditions
- Recurrent Bacterial Vaginitis
- Being tested
- vaginal flora transplant
- Keywords
- bacterial vaginitis, vaginal flora, microbiome
- 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 flora transplantBiological
| Study group | Role | What they receive |
|---|---|---|
| recurrent bacterial vaginitis | Experimental | Not described Receives: Biological: vaginal flora transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
relief of bacterial vaginosis
Clinical cure, i.e., absence of vaginal discharge and malodor
Measured: 12 month
Secondary outcomes (1)
Laboratory parameters
absence of all Amsel criteria and Nugent score<3.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJun 2015
- Primary completionMar 2025
- Study completionMar 2025
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 Recurrent Bacterial VaginitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahinoam Lev-Sagie, MD, Principal investigator, Hadassah Mediocal Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236429
- Sponsor's protocol ID
- VFT-HMO-CTIL
- Acronym
- VFT
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2014
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT02236429
- Acronym / sponsor ID
- VFT / VFT-HMO-CTIL
- Conditions
- Recurrent Bacterial Vaginitis
- Keywords
- bacterial vaginitis, vaginal flora, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Mar 2025 (actual)
- Study completion
- Mar 2025 (actual)
- First posted
- 10 Sep 2014 (estimated)
- 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.
Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is a high rate of recurrence. Almost half of women successfully treated suffer a recurrence within three months. Complications include risk factors for premature birth, increased transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The investigators proposed study is a cost effective treatment based on returning the normal microbial balance to the vagina. The investigators propose to transfer normal vaginal flora from healthy individuals to women with BV and thus restore normal vaginal flora and cure this disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| recurrent bacterial vaginitis | Experimental | Biological: vaginal flora transplant |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- recurrent BV (4 or more incidences in the past year)
- recurrence of BV in less than 2 months of antibiotic treatment or need for prophylactic antibiotic
- 3/4 Amsel criteria and Nugent criteria greater or equal to 7
Key exclusion criteria (4 listed)
- pregnancy or planned pregnancy during the study period
- other known diseases
- carriers of Hep B and C
- HIV or syphilis positive
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 flora transplant | Biological | recurrent bacterial vaginitis |
Primary outcome
relief of bacterial vaginosis
Time frame: 12 month
Clinical cure, i.e., absence of vaginal discharge and malodor
1 secondary outcome
Laboratory parameters
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: 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, MD principal investigator
Hadassah Mediocal Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal flora transplant in people with Recurrent Bacterial Vaginitis, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 2 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
relief of bacterial vaginosis (time frame: 12 month). 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 NCT02236429, 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 2 Oct 2026.