Transplanting vaginal microbiome to treat recurrent bacterial vaginosis
Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial
This study is testing if transplanting healthy vaginal bacteria can help women with recurring bacterial vaginosis that doesn't get better with antibiotics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 1 site (Jerusalem, Jerusalem) |
| Trial ID | NCT04517487 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Vaginal Microbiome Transplantation (VMT) as a treatment for recurrent bacterial vaginosis (BV) that does not respond to antibiotics. It is a randomized controlled trial comparing the transplantation of vaginal fluid from healthy donors to the patient's own vaginal fluid. The goal is to determine if VMT can provide a long-term solution for patients suffering from intractable BV. Previous preliminary studies have shown promising results in improving symptoms and microbiome composition.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-50 with a history of recurrent bacterial vaginosis requiring frequent antibiotic treatment.
Not a fit: Patients who are pregnant, have HIV, or are immunocompromised may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for patients with recurrent bacterial vaginosis who have not responded to traditional antibiotic therapies.
How similar studies have performed: Previous studies have shown some success with similar microbiome transplantation approaches, indicating potential for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jerusalem, Jerusalem
- Hadassah Medical Center — Jerusalem, Jerusalem, Israel (Recruiting)
Study contacts
- Principal investigator: Ahinoam Lev-Sagie — Hadassah Medical Organization
- Study coordinator: Ahinoam Lev-Sagie
- Email: levsagie@netvision.net.il
- Phone: +972544327178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.