Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis
Bacterial Vaginoses
About this trial
This is an interventional treatment trial for Bacterial Vaginoses
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Pregnancy or a planned pregnancy in the upcoming year
- Infection with HIV.
- Immunodeficiency status.
Sites / Locations
- Hadassah Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
VMT recipients
Placebo
In order to prevent transfer of pathogens, sperm, or antibiotic-resistant commensals we will establish a "vaginal fluid bank" in which samples from suitable donors will be kept for future use: Donors will be screened using a questionnaire addressing risk factors for potentially transmissible infections, undergo screening for cervico-vaginal infections, cervical cytology screening, and serology analysis for transmittable infections {see detailed screening in Lev-Sagie et al. Nat Med. 2019;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6.} The collected samples for VMT will be examined for bacteria,viruses and sperm. Before transplantation, patients will be treated with intravaginal antibiotics. A frozen specimen will be thawed at room temperature and will be placed in the patient's vagina. Following VMT, patients will be evaluated every 14 days for the first 2 months, then every month for additional 10 months.
Vaginal fluid of all recipients will be collected before initiation of the study using the same protocol, will be clearly labeled and will be kept frozen in similar conditions. These samples will be used in the placebo arm for autologous vaginal fluid transplantation. Before transplantation, patients will be treated with intravaginal antibiotic. Following Placebo, patients will be evaluated every 14 days for the first 2 months, then every month for additional 2-4 months. After 4-6 months, patients who initially received placebo will be offered a VMT in case they are still symptomatic and fulfill inclusion criteria, in an open-label phase.