Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorHadassah Medical Organization

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnancy or a planned pregnancy in the upcoming year

Infection with HIV.

Immunodeficiency status.

Trial design

Treatments tested in this trial

  • Vaginal Microbiome Transplantation (VMT)
  • Placebo

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hadassah Medical Organization

Lead sponsor

Weizmann Institute of Science

Collaborator