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Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

NCT04517487 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-19

No results posted yet for this study

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.

Conditions

  • Bacterial Vaginoses

Interventions

BIOLOGICAL

Vaginal Microbiome Transplantation (VMT)

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

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • Weizmann Institute of Science

    collaborator OTHER

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Ahinoam Lev-Sagie · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Israel

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04517487 on ClinicalTrials.gov