Vaginal Flora for Treatment of Bacterial Vaginosis (VFT)
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ClinicalTrials.gov Identifier: NCT02236429 |
Recruitment Status :
Active, not recruiting
First Posted : September 10, 2014
Last Update Posted : August 9, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent Bacterial Vaginitis | Biological: vaginal flora transplant | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis |
Actual Study Start Date : | June 2015 |
Estimated Primary Completion Date : | March 2023 |
Estimated Study Completion Date : | March 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: recurrent bacterial vaginitis |
Biological: vaginal flora transplant |
- relief of bacterial vaginosis [ Time Frame: 12 month ]Clinical cure, i.e., absence of vaginal discharge and malodor
- Laboratory parameters [ Time Frame: 12 months ]absence of all Amsel criteria and Nugent score<3.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- pregnancy or planned pregnancy during the study period
- other known diseases
- carriers of Hep B and C
- HIV or syphilis positive

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236429
Israel | |
Hadassah Medical Organization | |
Jerusalem, Israel |
Principal Investigator: | Ahinoam Lev-Sagie, MD | Hadassah Mediocal Organization |
Responsible Party: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT02236429 |
Other Study ID Numbers: |
VFT-HMO-CTIL |
First Posted: | September 10, 2014 Key Record Dates |
Last Update Posted: | August 9, 2022 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
bacterial vaginitis vaginal flora microbiome |
Vaginosis, Bacterial Vaginitis Vaginal Diseases |
Bacterial Infections Bacterial Infections and Mycoses Infections |