drugset / Trial / NCT04410003

Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis

NCT04410003

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2020-06-02
Primary completion
2025-07-01
Completion
2025-07-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fecal Microbial Transplant Other / unclassified Oral

Indications