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Vaginal Flora for Treatment of Bacterial Vaginosis

Study acronym: VFT
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 5 participants (planned 10)
    • Primary completion date changed from estimate of Mar 2026 to Mar 2025
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Mar 2023 to Mar 2026
    • Study completion date: Mar 2024 to Mar 2026
    v11
  3. Study completion date: Mar 2023 to Mar 2024v10
  4. Primary and study completion dates: Mar 2022 to Mar 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary and study completion dates: Mar 2020 to Mar 2022v7
  2. Re-verified, no change to tracked fieldsv6
  3. Primary completion date: Mar 2018 to Mar 2020
    • Study completion date: Mar 2019 to Mar 2020
    v5
  4. Primary completion date: Mar 2017 to Mar 2018
    • Study completion date: Mar 2018 to Mar 2019
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 2016 to Mar 2017
    • Study completion date: Mar 2017 to Mar 2018
    • Site details revised
    v3
  6. Start date: Nov 2014 to Jun 2015v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02236429
Lead Sponsor Hadassah Medical Organization
Conditions
(from sponsor)		 Recurrent Bacterial Vaginitis
Related terms Vaginosis, Bacterial
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov