Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04517487

Enrollment

Registered

2020-08-18

Start date

2020-08-20

Completion date

2026-12-01

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginoses

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) saline (placebo).

Interventions

BIOLOGICALVaginal Microbiome Transplantation (VMT)

Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome

BIOLOGICALPlacebo

Placebo

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

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
Clinical parameters- patient's complains	Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.	Number of participants reporting disappearance of discharge and odor
Laboratory parameters- Amsel criteria	Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.	Presence or absence of each Amsel criteria (discharge, pH\>4.5, positive whiff test and clue cells on microscopy)/
Vaginal fluid microscopy	Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.	Presence of Lactobacillus-dominant microbiome on microscopy
Microbiome composition	Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.	Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing

Countries

Israel

Contacts

PRINCIPAL_INVESTIGATORAhinoam Lev-Sagie

Hadassah Medical Organization

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026