Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- relief of bacterial vaginosis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
recurrent bacterial vaginitis
Intervention: vaginal flora transplant (Biological)
Outcomes
Primary Outcomes
relief of bacterial vaginosis
Time Frame: 12 month
Clinical cure, i.e., absence of vaginal discharge and malodor
Secondary Outcomes
- Laboratory parameters(12 months)