Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

NCT ID: NCT04517487

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-20
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VMT recipients

In order to prevent transfer of pathogens, sperm, or antibiotic-resistant commensals we will establish a "vaginal fluid bank" in which samples from suitable donors will be kept for future use:

• Donors will be screened using a questionnaire addressing risk factors for potentially transmissible infections, undergo screening for cervico-vaginal infections, cervical cytology screening, and serology analysis for transmittable infections {see detailed screening in Lev-Sagie et al. Nat Med. 2019;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6.}
• The collected samples for VMT will be examined for bacteria,viruses and sperm.

Before transplantation, patients will be treated with intravaginal antibiotics. A frozen specimen will be thawed at room temperature and will be placed in the patient's vagina.

Following VMT, patients will be evaluated every 14 days for the first 2 months, then every month for additional 10 months.

Group Type: ACTIVE_COMPARATOR

Vaginal Microbiome Transplantation (VMT)

Intervention Type: BIOLOGICAL

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

Placebo

Vaginal fluid of all recipients will be collected before initiation of the study using the same protocol, will be clearly labeled and will be kept frozen in similar conditions. These samples will be used in the placebo arm for autologous vaginal fluid transplantation.

Before transplantation, patients will be treated with intravaginal antibiotic.

Following Placebo, patients will be evaluated every 14 days for the first 2 months, then every month for additional 2-4 months.

After 4-6 months, patients who initially received placebo will be offered a VMT in case they are still symptomatic and fulfill inclusion criteria, in an open-label phase.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo

Interventions

Vaginal Microbiome Transplantation (VMT)

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

Intervention Type: BIOLOGICAL

Placebo

Placebo

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Weizmann Institute of Science

OTHER

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Ahinoam Lev-Sagie

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahinoam Lev-Sagie

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ahinoam Lev-Sagie

Role: CONTACT

levsagie@netvision.net.il

+972544327178

Facility Contacts

Ahinoam Lev-Sagie, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 31591599 (View on PubMed)

Other Identifiers

HMO-19-691

Identifier Type: -

Identifier Source: org_study_id