Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02236429

Vaginal Flora for Treatment of Bacterial Vaginosis

Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is a high rate of recurrence. Almost half of women successfully treated suffer a recurrence within three months. Complications include risk factors for premature birth, increased transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The investigators proposed study is a cost effective treatment based on returning the normal microbial balance to the vagina. The investigators propose to transfer normal vaginal flora from healthy individuals to women with BV and thus restore normal vaginal flora and cure this disorder.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Recurrent Bacterial Vaginitis 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 Organization

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • recurrent BV (4 or more incidences in the past year)
  • recurrence of BV in less than 2 months of antibiotic treatment or need for prophylactic antibiotic
  • 3/4 Amsel criteria and Nugent criteria greater or equal to 7

Exclusion criteria

  • pregnancy or planned pregnancy during the study period
  • other known diseases
  • carriers of Hep B and C
  • HIV or syphilis positive

Treatment and study plan

vaginal flora transplant

Biological

Primary outcomes

  1. relief of bacterial vaginosis

    Time frame: 12 month

    Clinical cure, i.e., absence of vaginal discharge and malodor

Secondary outcomes

  1. Laboratory parameters

    Time frame: 12 months

    absence of all Amsel criteria and Nugent score<3.

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis

Acronym: VFT

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2014
Registry last updated
Sep 24, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.