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Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 17, 2024 (before its estimated July 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Apr 30, 2024 to Jul 1, 2025
    • Study completion date: Apr 30, 2025 to Jul 30, 2025
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Apr 30, 2022 to Apr 30, 2024
    • Study sites: 0 to 1
    • Study completion date: Apr 30, 2022 to Apr 30, 2025
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients with unexplained atherosclerosis (severe atherosclerosis not explained by traditional risk factors) will receive fecal microbial transplants (FMT) from patients with a Protected phenotype (patients who have high levels of risk factors but little or no carotid atherosclerosis). The objective is to determine what changes in the intestinal microbiome are associated with a decline in plasma levels of toxic metabolites of the itnestinal microbiome such as trimethylamine N-oxide (TMAO) and p-cresylsulfate. The intention is to develop an ecosystem therapeutic of cultured bacteria to treat atherosclerosis.
Trial Details
NCT Number NCT04410003
Lead Sponsor Western University, Canada
Collaborators: European Bioinformatics Institute
Conditions
(from sponsor)		 Atherosclerosis, Intestinal Microbiome
Related terms Atherosclerosis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov