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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome
Placebo
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
RECRUITINGClinical parameters- patient's complains
Number of participants reporting disappearance of discharge and odor
Time frame: 12 months
Laboratory parameters- Amsel criteria
Presence or absence of each Amsel criteria (discharge, pH\>4.5, positive whiff test and clue cells on microscopy)/
Time frame: 12 months
Vaginal fluid microscopy
Presence of Lactobacillus-dominant microbiome on microscopy
Time frame: 12 months
Microbiome composition
Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing
Time frame: 12 months
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