Vaginal Flora for Treatment of Bacterial Vaginosis (VFT)
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ClinicalTrials.gov Identifier: NCT02236429 |
Recruitment Status :
Active, not recruiting
First Posted : September 10, 2014
Last Update Posted : August 9, 2022
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Sponsor:
Hadassah Medical Organization
Information provided by (Responsible Party):
Hadassah Medical Organization
Tracking Information | ||||
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First Submitted Date ICMJE | September 7, 2014 | |||
First Posted Date ICMJE | September 10, 2014 | |||
Last Update Posted Date | August 9, 2022 | |||
Actual Study Start Date ICMJE | June 2015 | |||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
relief of bacterial vaginosis [ Time Frame: 12 month ] Clinical cure, i.e., absence of vaginal discharge and malodor
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Laboratory parameters [ Time Frame: 12 months ] absence of all Amsel criteria and Nugent score<3.
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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 | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Recurrent Bacterial Vaginitis | |||
Intervention ICMJE | Biological: vaginal flora transplant | |||
Study Arms ICMJE | Experimental: recurrent bacterial vaginitis
Intervention: Biological: vaginal flora transplant
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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;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6. Epub 2019 Oct 7. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Estimated Enrollment ICMJE |
10 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | March 2023 | |||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
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 |
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Current Responsible Party | Hadassah Medical Organization | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Hadassah Medical Organization | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Hadassah Medical Organization | |||
Verification Date | August 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |