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RECRUITING
NCT04517487
NA

Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

Sponsor: Hadassah Medical Organization

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Vaginal Microbiome Transplantation (VMT)

Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome

BIOLOGICAL

Placebo

Placebo

Locations (1)

Hadassah Medical Center

Jerusalem, Jerusalem, Israel