Vaginal Flora for Treatment of Bacterial Vaginosis (VFT)

Hadassah Medical Center

Status: Active, not recruiting

Conditions: Recurrent Bacterial Vaginitis

Treatments: Biological: vaginal flora transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT02236429

VFT-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

recurrent bacterial vaginitis

Experimental group

Treatment:

Biological: vaginal flora transplant