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Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)

Study acronym: DEKODON
StatusUnknown
PhasePhase 2/3
Started
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Record status
This record was last updated September 19, 2024 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Study Identification, Study Status, Oversightv5
  3. Primary completion date: Dec 30, 2023 to Dec 30, 2025
    • Study completion date: Dec 30, 2024 to Dec 30, 2025
    v4
  4. Primary completion date: Dec 30, 2021 to Dec 30, 2023
    • Study completion date: Dec 30, 2023 to Dec 30, 2024
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 20, 2019 to Dec 18, 2019
    • Study title expanded, about 2 words
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Colonization by Multiple Drug Resistant Organisms (MDROs) during patient hospitalization requires expensive isolation measures and renders the return or transfer to other departments or institutions often impossible. Currently there is no specific treatment available. Patients have to wait for spontaneous clearance which can take months or does not happen at all. The study will test the effect of Fecal Microbiota Transfer (FMT) on gut MDRO colonization. The focus will be on patients with a long-term colonization by Gram-negative bacteria for which isolation is warranted. Participants will be randomized into two treatment groups; allogenic FMT versus autologous FMT. A third group of participants will be monitored but will not receive an FMT. Decolonization rate will be compared one month after treatment. Additionally gut microbial composition will be studied up to one year after FMT.
Trial Details
NCT Number NCT04188743
Lead Sponsor University Hospital, Ghent
Collaborators: Research Foundation Flanders
Conditions
(from sponsor)		 Resistance Bacterial
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov