drugset / Trial / NCT04410003
Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis
Phase 1
Recruiting
100 enrolled
Western University, Canada
European Bioinformatics Institute · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fecal Microbial Transplant | Other / unclassified | — | Oral |