Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial

NCT04517487 NA RECRUITING

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.

Details

Lead sponsor	Hadassah Medical Organization
Phase	NA
Status	RECRUITING
Enrolment	100
Start date	2020-08-20
Completion	2026-12

Conditions

• Bacterial Vaginoses

Interventions

• Vaginal Microbiome Transplantation (VMT)
• Placebo

Primary outcomes

• 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)/
• 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

Countries

Israel