Vaginal Flora for Treatment of Bacterial Vaginosis (VFT)

• ClinicalTrials.gov Identifier: NCT02236429
• Recruitment Status: Recruiting
• First Posted: September 10, 2014
• Last Update Posted: August 20, 2019
• Sponsor: Hadassah Medical Organization
• Information provided by (Responsible Party): Hadassah Medical Organization

Tracking Information

• First Submitted Date: September 7, 2014
• First Posted Date: September 10, 2014
• Last Update Posted Date: August 20, 2019
• Actual Study Start Date: June 2015
• Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 9, 2014)

relief of bacterial vaginosis [ Time Frame: 12 month ]

Clinical cure, i.e., absence of vaginal discharge and malodor

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02236429 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: September 9, 2014)

Laboratory parameters [ Time Frame: 12 months ]

absence of all Amsel criteria and Nugent score<3.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vaginal Flora for Treatment of Bacterial Vaginosis
• Official Title: Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Recurrent Bacterial Vaginitis
• Intervention: Biological: vaginal flora transplant

Study Arms

Experimental: recurrent bacterial vaginitis

Intervention: Biological: vaginal flora transplant

• Publications *: Lev-Sagie A, Goldman-Wohl D, Cohen Y, Dori-Bachash M, Leshem A, Mor U, Strahilevitz J, Moses AE, Shapiro H, Yagel S, Elinav E. Vaginal microbiome transplantation in women with intractable bacterial vaginosis. Nat Med. 2019 Oct 7. doi: 10.1038/s41591-019-0600-6. [Epub ahead of print]

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 9, 2014): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2020
• Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ahinoam Lev-Sagie, MD; +972-544327178; levsagie@netvision.net.it

• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT02236429
• Other Study ID Numbers: VFT-HMO-CTIL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Hadassah Medical Organization
• Study Sponsor: Hadassah Medical Organization
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ahinoam Lev-Sagie, MD; Hadassah Mediocal Organization

• PRS Account: Hadassah Medical Organization
• Verification Date: June 2019