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NCT Number: NCT04517487

Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Center

Jerusalem, 9765422, Israel

Location status: Recruiting

Location contact

Ahinoam Lev-Sagie, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaginal Microbiome Transplantation (VMT)

Biological

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

Placebo

Biological

Placebo

Primary outcomes

  1. Clinical parameters- patient's complains

    Time frame: 12 months

    Number of participants reporting disappearance of discharge and odor

  2. Laboratory parameters- Amsel criteria

    Time frame: 12 months

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

  3. Vaginal fluid microscopy

    Time frame: 12 months

    Presence of Lactobacillus-dominant microbiome on microscopy

  4. Microbiome composition

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahinoam Lev-Sagie

CONTACT

[email protected]

+972544327178

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Weizmann Institute of Science

Registry information

Official study title

Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis-A Placebo, Randomized, Controlled Trial

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2020
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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