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Vaginal Flora for Treatment of Bacterial Vaginosis (VFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02236429
Recruitment Status : Recruiting
First Posted : September 10, 2014
Last Update Posted : August 20, 2019
Information provided by (Responsible Party):
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE September 7, 2014
First Posted Date  ICMJE September 10, 2014
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT02236429 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
Laboratory parameters [ Time Frame: 12 months ]
absence of all Amsel criteria and Nugent score<3.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Vaginal Flora for Treatment of Bacterial Vaginosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Bacterial Vaginitis
Intervention  ICMJE Biological: vaginal flora transplant
Study Arms  ICMJE 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]

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2014)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ahinoam Lev-Sagie, MD +972-544327178
Listed Location Countries  ICMJE Israel
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02236429
Other Study ID Numbers  ICMJE VFT-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahinoam Lev-Sagie, MD Hadassah Mediocal Organization
PRS Account Hadassah Medical Organization
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP