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Fecal Microbiota Transplantation as a Strategy to Eradicate Resistant Organisms

StatusUnknown
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 23, 2021 (before its estimated September 2023 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2021); last known: Recruiting
  2. Primary completion date: Sep 2021 to Sep 2023
    • Study completion date: Sep 2024 to Sep 2026
    v6
  3. Primary completion date: Sep 2020 to Sep 2021v5
  4. Primary completion date: Sep 2018 to Sep 2020
    • Study completion date: Sep 2022 to Sep 2024
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 2016 to Feb 17, 2017
    • Study sites: 0 to 1
    v3
  6. Start date: Dec 2015 to May 2016v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This protocol will evaluate fecal microbiota transplantation (FMT) as a strategy to eradicate intestinal colonization of extended-spectrum resistant (ESC-R) Enterobacteriaceae in pediatric patients. FMT will be performed on subjects with a history of at least one infection due to ESC-R Enterobacteriaceae. This protocol aims to determine the feasibility, safety, tolerability, and potential efficacy of FMT in pediatric patients with a history of ESC-R Enterobacteriaceae.
Trial Details
NCT Number NCT02543866
Lead Sponsor Seattle Children's Hospital
Conditions
(from sponsor)		 Infection Resistant to Drugs
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov