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Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 70% 100 → 30 participants
See other at-risk trials from Hadassah Medical Organization

Record History

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  1. Primary endpoints: details revised at 1 of 4 entries Show 4 more changesShow less
    • Interventions modified
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 529 words
    • Publications: details revised at 1 of 1 entry
  2. Enrollment reduced: 100 → 30 participants
    • Phase changed: not applicable → Phase 1/2
    • Enrollment closed, study ongoing
    • Site details revised
    v6
  3. Primary completion date: Dec 2024 to Dec 2026
    • Study completion date: Aug 2025 to Dec 2026
    • Site details revised
    v5
  4. Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Aug 2024 to Aug 2025
    v4
  5. Primary completion date: Dec 2021 to Dec 2023
    • Study completion date: Aug 2022 to Aug 2024
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Vaginal Microbiome Transplantation (VMT) may be beneficial in treating the most severe cases of recurrent and antibiotics-nonresponsive cases of BV. We completed a preliminary study in which we treated patients with recurrent and antibiotics-non-responsive, intractable BV, with VMT from healthy donors \[Lev-Sagie, Nature Medicine 2019\]. Four VMT recipients in this preliminary study featured a significant improvement of both clinical symptoms and dysbiotic vaginal microbiome composition and function, which persisted over a long follow-up period, while one recipient featured a partial remission. The proposed study is designed as a placebo, randomized controlled trial, and is aimed to further assess whether VMT may serve as a viable option in symptomatic, intractable BV. In the suggested study, we compare transplantation of: 1) vaginal fluid from healthy donors (VMT), and 2) saline and glycerol (placebo).
Trial Details
NCT Number NCT04517487
Lead Sponsor Hadassah Medical Organization
Collaborators: Weizmann Institute of Science
Conditions
(from sponsor)		 Bacterial Vaginoses
Related terms Vaginosis, Bacterial
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov