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Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis
Sponsor: Hadassah Medical Organization
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 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.
Official title: Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2020-08-20
Completion Date
2026-12
Last Updated
2025-03-19
Healthy Volunteers
No
Conditions
Interventions
Vaginal Microbiome Transplantation (VMT)
Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome
Placebo
Placebo
Locations (1)
Hadassah Medical Center
Jerusalem, Jerusalem, Israel