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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Severe atherosclerosis, with total plaque area in the top quartile (\>119 mm2), not explained by traditional risk factors in linear regression (residual score \>= 2)
Exclusion Criteria:
* 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).
Primary outcome measure(s)
Changes in plasma levels of metabolites of the intestinal microbiome — 6 weeks and 12 months The primary outcome is changes in plasma levels of trimethylamine N-oxide and p-cresylsulfate
Metagenomic changes of the intestinal microbiome — 6 weeks and 12 months Metagenomic changes in the stool of transplant recipients will be analyzed to determine what changes in the intestinal bacteria are associated with changes in the plasma levels of the intestinal metabolites.
Trial sites (1)
Facility
City
Region
Status
Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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