Recurrent Bacterial Vaginitis
Conditions
Keywords
bacterial vaginitis, vaginal flora, microbiome
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.
Interventions
BIOLOGICALvaginal flora transplant
Sponsors
Hadassah Medical Organization
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| relief of bacterial vaginosis | 12 month | Clinical cure, i.e., absence of vaginal discharge and malodor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory parameters | 12 months | absence of all Amsel criteria and Nugent score\<3. |
Countries
Israel
Outcome results
None listed