Active — Not RecruitingPhase 1/2

Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

Israel30 participantsStarted 2020-08-20

Plain-language 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).

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical parameters- patient's complains

Timeframe: Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.

Laboratory parameters- Amsel criteria

Timeframe: Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.

Vaginal fluid microscopy

Timeframe: Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.

Microbiome composition

Timeframe: Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.

Trial details

NCT IDNCT04517487

SponsorHadassah Medical Organization

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Bacterial Vaginoses trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Clinical parameters- patient's complains

Timeframe: Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.

Laboratory parameters- Amsel criteria

Timeframe: Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.

Vaginal fluid microscopy

Timeframe: Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.

Microbiome composition

Timeframe: Interim analysis at 4 months from initail intrvention, and final analysis at 12 months.