Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

NCT04517487 | Active Not Recruiting Phase 1

• 1 other identifier: HMO-19-691
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Vaginal Microbiome Transplantation (VMT) may be beneficial in treating the most severe cases of recurrent and antibiotics-nonresponsive cases of BV. 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 compare transplantation of: 1) vaginal fluid from healthy donors (VMT), and 2) saline and glycerol (placebo).

Conditions

Bacterial Vaginoses

Outcome Measures

Primary Outcomes (4)

• Clinical parameters- patient's complains

  participants report disappearance of discharge and odor.

  Interim analysis at 4 months from initial intervention, and final analysis at 12 months.

• Laboratory parameters- Amsel criteria

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

  Interim analysis at 4 months from initial intervention, and final analysis at 12 months.

• Vaginal fluid microscopy

  Defined as normal (lactobacilli dominated), BV (coccid-bacillary dominated) or mixed.

  Interim analysis at 4 months from initial intervention, and final analysis at 12 months.

• Microbiome composition

  Characterization of the vaginal microbial community using shotgun analysis or 16S rRNA sequencing.

  Interim analysis at 4 months from initial intervention, and final analysis at 12 months.

Study Arms (2)

VMT recipients

EXPERIMENTAL

vaginal microbiome transplant from healthy donors 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 month, then every month for additional 11 months.

Biological: Vaginal Microbiome Transplantation (VMT)

Placebo

PLACEBO COMPARATOR

Saline with glycerol will be used as placebo. Before transplantation, patients will be treated with intravaginal antibiotic. Following Placebo, patients will be evaluated every 14 days for the first month, then every month for additional 3 months (total of 4 months) After 4 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.

Other: Placebo

Interventions

Placebo OTHER

saline mixed with glycerol (10-20% total concentration).

Placebo

Vaginal Microbiome Transplantation (VMT) BIOLOGICAL

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

VMT recipients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or a planned pregnancy in the upcoming year
• Infection with HIV.
• Immunodeficiency status.

Sponsors & Collaborators

• Weizmann Institute of Science: collaborator
• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 9765422, Israel

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ahinoam Lev-Sagie

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants will be blinded to the therapy given. At the 4 months post transplantation timepoint, in case they are still symptomatic and fulfill inclusion criteria, patients who initially received placebo will be unblinded and offered a VMT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 18, 2020
• Study Start: August 20, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)