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Vaginal Flora for Treatment of Bacterial Vaginosis (VFT)

Primary Purpose

Recurrent Bacterial Vaginitis

Status
Active
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
vaginal flora transplant
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Bacterial Vaginitis focused on measuring bacterial vaginitis, vaginal flora, microbiome

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

recurrent bacterial vaginitis

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Laboratory parameters
absence of all Amsel criteria and Nugent score<3.

Full Information

First Posted
September 7, 2014
Last Updated
September 22, 2023
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT02236429
Brief Title
Vaginal Flora for Treatment of Bacterial Vaginosis
Acronym
VFT
Official Title
Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2015 (Actual)
Primary Completion Date
March 2023 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Bacterial Vaginitis
Keywords
bacterial vaginitis, vaginal flora, microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
recurrent bacterial vaginitis
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
vaginal flora transplant
Primary Outcome Measure Information:
Title
relief of bacterial vaginosis
Description
Clinical cure, i.e., absence of vaginal discharge and malodor
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Laboratory parameters
Description
absence of all Amsel criteria and Nugent score<3.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahinoam Lev-Sagie, MD
Organizational Affiliation
Hadassah Mediocal Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31591599
Citation
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;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6. Epub 2019 Oct 7.
Results Reference
derived

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Vaginal Flora for Treatment of Bacterial Vaginosis

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