Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vaginal Microbiome Transplantation (VMT), Placebo.
- Who it may be relevant to
- Registry conditions: Bacterial Vaginoses. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial
Overview
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.
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
Primary outcome measures
- Clinical parameters- patient's complains [Time frame: 12 months]
- Laboratory parameters- Amsel criteria [Time frame: 12 months]
- Vaginal fluid microscopy [Time frame: 12 months]
- Microbiome composition [Time frame: 12 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Hadassah Medical Center — Jerusalem
Publications
- Lev-Sagie A, Goldman-Wohl D, Cohen Y, Dori-Bachash M, Leshem A, Mor U, Strahilevitz J, Moses AE, Shapiro H, Yagel S, Elinav E. Vaginal microbiome transplantation in women with intractable bacterial vaginosis. Nat Med. 2019 Oct;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6. Epub 2019 Oct 7. PMID 31591599
Identifiers
NCT: NCT04517487 · HMO-19-691