- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02236429
Vaginal Flora for Treatment of Bacterial Vaginosis (VFT)
September 22, 2023 updated by: Hadassah Medical Organization
Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jerusalem, Israel
- Hadassah Medical Organization
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: recurrent bacterial vaginitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
relief of bacterial vaginosis
Time Frame: 12 month
|
Clinical cure, i.e., absence of vaginal discharge and malodor
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Laboratory parameters
Time Frame: 12 months
|
absence of all Amsel criteria and Nugent score<3.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahinoam Lev-Sagie, MD, Hadassah Mediocal Organization
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Actual)
March 1, 2023
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
September 7, 2014
First Submitted That Met QC Criteria
September 9, 2014
First Posted (Estimated)
September 10, 2014
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VFT-HMO-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Bacterial Vaginitis
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Kaiser PermanenteWithdrawnRecurrent Bacterial VaginosisUnited States
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University of Alabama at BirminghamWayne State UniversityCompletedRecurrent Bacterial VaginosisUnited States
-
Starpharma Pty LtdCompletedRecurrent Bacterial Vaginosis (BV)
-
Dongfang Hospital Beijing University of Chinese...Peking University First Hospital; Beijing Compete Pharmaceutical Co., Ltd.; Shandong...Unknown
-
Osmaniye Korkut Ata UniversityCompleted
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Indiana UniversityLupin Pharmaceuticals, Inc.CompletedRecurrent Bacterial VaginosisUnited States
-
IBSS Biomed S.A.CompletedBacterial Vaginosis | Bacterial Vaginitis
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Meir Medical CenterRecruitingAtrophic Vaginitis | Bacterial Vaginosis | Trichomonas Vaginitis | Candida Vulvovaginitis | Candida Albicans Vulvovaginitis | Desquamative Inflammatory VaginitisIsrael
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National Institute of Allergy and Infectious Diseases...CompletedVaginitis GardnerellaUnited States
-
National Institute of Allergy and Infectious Diseases...Terminated
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