Clinical Trial

Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis

Recruiting Phase 1
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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.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2020-05-27; most recent amendment 2024-10-15.
Status change: Not Yet Recruiting → Recruiting 2024-04-23
Trial Details
NCT Number NCT04410003
Lead Sponsor Western University, Canada
Collaborators: European Bioinformatics Institute
Conditions Atherosclerosis, Intestinal Microbiome
Enrollment 100 participants
Start Date 2020-06-02
Primary Completion 2025-07-01 (estimated)
Study Completion 2025-07-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-17