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Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

ConditionBacterial Vaginoses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorHadassah Medical Organization

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy or a planned pregnancy in the upcoming year

Infection with HIV.

Immunodeficiency status.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vaginal Microbiome Transplantation (VMT)

    Biological/Vaccine

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

  • Placebo

    Biological/Vaccine

    Placebo

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: VMT recipientsActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical parameters- patient's complains

Number of participants reporting disappearance of discharge and odor

Time frame
12 months
2

Laboratory parameters- Amsel criteria

Presence or absence of each Amsel criteria (discharge, pH\>4.5, positive whiff test and clue cells on microscopy)/

Time frame
12 months
3

Vaginal fluid microscopy

Presence of Lactobacillus-dominant microbiome on microscopy

Time frame
12 months
4

Microbiome composition

Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hadassah Medical Organization

Lead sponsor

Weizmann Institute of Science

Collaborator

Source ClinicalTrials.gov
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