Status:
RECRUITING
Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Weizmann Institute of Science
Conditions:
Bacterial Vaginoses
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Vaginal Microbiome Transplantation (VMT) may be beneficial in treating the most severe cases of recurrent and antibiotics-nonresponsive cases of BV. Recently, we completed a preliminary study in which...
Eligibility Criteria
Inclusion
- 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
- Pregnancy or a planned pregnancy in the upcoming year
- Infection with HIV.
- Immunodeficiency status.
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04517487
Start Date
August 20 2020
End Date
December 1 2026
Last Update
March 19 2025
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Jerusalem, Israel, 9765422