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Vaginal Flora for Treatment of Bacterial Vaginosis (VFT)

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent Bacterial Vaginitis Biological: vaginal flora transplant Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis
Actual Study Start Date : June 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: recurrent bacterial vaginitis Biological: vaginal flora transplant


Outcome Measures
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Primary Outcome Measures :
  1. relief of bacterial vaginosis [ Time Frame: 12 month ]
    Clinical cure, i.e., absence of vaginal discharge and malodor


Secondary Outcome Measures :
  1. Laboratory parameters [ Time Frame: 12 months ]
    absence of all Amsel criteria and Nugent score<3.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236429


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

Locations
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Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Ahinoam Lev-Sagie, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Ahinoam Lev-Sagie, MD Hadassah Mediocal Organization
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02236429     History of Changes
Other Study ID Numbers: VFT-HMO-CTIL
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hadassah Medical Organization:
bacterial vaginitis
vaginal flora
microbiome
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections