Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Atherosclerosis, Intestinal Microbiome
In brief
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.
Key facts
- Study ID
- NCT04410003
- Run by
- Western University, Canada
- People needed
- 100
- Starts
- 2020-06-02
- Expected to finish
- 2025-07-30
- Last updated by the study team
- 2024-10-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Severe atherosclerosis, with total plaque area in the top quartile (>119 mm2), not explained by traditional risk factors in linear regression (residual score >= 2)
You may not qualify if…
- Excluded will be patients unwilling/unable to provide informed consent, unwilling to ingest the stool capsules at baseline, patients with moderate to severe renal failure (eGFR<50), immunosuppressed patients, and patients with cancer, unstable angina, planned carotid revascularization or other conditions that might be expected to reduce their survival to < 1 year (including age >80).
Where it is running
- Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute — London, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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