Bacterial Vaginoses
Conditions
Brief 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.
Interventions
BIOLOGICALVaginal Microbiome Transplantation (VMT)
Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome
BIOLOGICALPlacebo
Placebo
Sponsors
Weizmann Institute of Science
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal fluid microscopy | 12 months | Presence of Lactobacillus-dominant microbiome on microscopy |
| Microbiome composition | 12 months | Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing |
| Clinical parameters- patient's complains | 12 months | Number of participants reporting disappearance of discharge and odor |
| Laboratory parameters- Amsel criteria | 12 months | Presence or absence of each Amsel criteria (discharge, pH\>4.5, positive whiff test and clue cells on microscopy)/ |
Countries
Israel
Contacts
Primary ContactAhinoam Lev-Sagie
Outcome results
None listed