Vaginal Flora for Treatment of Bacterial Vaginosis
- Conditions
- Recurrent Bacterial Vaginitis
- Interventions
- Biological: vaginal flora transplant
- Registration Number
- NCT02236429
- Lead Sponsor
- Hadassah Medical Organization
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 10
- 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
- pregnancy or planned pregnancy during the study period
- other known diseases
- carriers of Hep B and C
- HIV or syphilis positive
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description recurrent bacterial vaginitis vaginal flora transplant -
- Primary Outcome Measures
Name Time Method relief of bacterial vaginosis 12 month Clinical cure, i.e., absence of vaginal discharge and malodor
- Secondary Outcome Measures
Name Time Method Laboratory parameters 12 months absence of all Amsel criteria and Nugent score\<3.
Trial Locations
- Locations (1)
Hadassah Medical Organization
🇮🇱Jerusalem, Israel