Actively Recruiting
Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis
Led by Hadassah Medical Organization · Updated on 2025-03-19
100
Participants Needed
1
Research Sites
327 weeks
Total Duration
On this page
Sponsors
H
Hadassah Medical Organization
Lead Sponsor
W
Weizmann Institute of Science
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 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 plan to compare transplantation of: 1) vaginal fluid from healthy donors, and 2) autologous transplantation, of the patient's own vaginal fluid.
CONDITIONS
Official Title
Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 50 years
- Recurrent bacterial vaginosis with 4 or more symptomatic episodes in the last year
- Requires maintenance antibiotic treatment twice weekly to remain symptom-free or experiences recurrence within 2 months after antibiotic treatment
- Otherwise healthy
- Uses contraception
You will not qualify if you...
- Currently pregnant or planning pregnancy within the next year
- Infection with HIV
- Immunodeficiency status
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hadassah Medical Center
Jerusalem, Jerusalem, Israel, 9765422
Actively Recruiting
Research Team
A
Ahinoam Lev-Sagie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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