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Clinical Trials in Israel / NCT04517487
Active, not recruiting Phase 1/2

Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

NCT04517487 · tracked via the Priya Life Science Israel tracker
Sponsor
Hadassah Medical Organization
Phase
Phase 1/2
Started
2020-08-20
Last updated
2026-09-28

Condition(s) studied

Bacterial Vaginoses

Investigational drug(s) / intervention(s)

Vaginal Microbiome Transplantation (VMT)Placebo

Vaginal Microbiome Transplantation (VMT): Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome

Placebo: saline mixed with glycerol (10-20% total concentration).

Study summary

Vaginal Microbiome Transplantation (VMT) may be beneficial in treating the most severe cases of recurrent and antibiotics-nonresponsive cases of BV.

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 compare transplantation of: 1) vaginal fluid from healthy donors (VMT), and 2) saline and glycerol (placebo).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
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.

Primary outcome measure(s)

  • Clinical parameters- patient's complains — Interim analysis at 4 months from initial intervention, and final analysis at 12 months.
    participants report disappearance of discharge and odor.
  • Laboratory parameters- Amsel criteria — Interim analysis at 4 months from initial intervention, and final analysis at 12 months.
    Presence or absence of Amsel criteria (discharge, pH\>4.5, positive whiff test and clue cells on microscopy).
  • Vaginal fluid microscopy — Interim analysis at 4 months from initial intervention, and final analysis at 12 months.
    Defined as normal (lactobacilli dominated), BV (coccid-bacillary dominated) or mixed.
  • Microbiome composition — Interim analysis at 4 months from initial intervention, and final analysis at 12 months.
    Characterization of the vaginal microbial community using shotgun analysis or 16S rRNA sequencing.

Trial sites (1)

FacilityCityRegionStatus
Hadassah Medical Center Jerusalem Israel

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04517487 on ClinicalTrials.gov ↗ ← All trials in Israel