Vaginal Flora for Treatment of Bacterial Vaginosis

Recurrent Bacterial Vaginitis Clinical Trial

— VFT  

Official title:

Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02236429
• Other study ID #: VFT-HMO-CTIL
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: March 2024
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrent Bacterial Vaginitis
• Vaginitis
• Vaginosis, Bacterial

Intervention

Biological:
• vaginal flora transplant

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relief of bacterial vaginosis	Clinical cure, i.e., absence of vaginal discharge and malodor	12 month
Secondary	Laboratory parameters	absence of all Amsel criteria and Nugent score<3.	12 months