Effects of gut microbiome transplants on unexplained atherosclerosis
Metabolic and Metagenomic Effects of Repopulation of the Intestinal Microbiome in Patients with Severe Unexplained Atherosclerosis
PHASE1 · Western University, Canada · NCT04410003
This study is testing whether gut bacteria from healthy donors can help people with unexplained atherosclerosis improve their condition.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western University, Canada (other) |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT04410003 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of fecal microbial transplants (FMT) from donors with a protected phenotype on patients suffering from unexplained atherosclerosis. A total of 100 patients will be randomized to receive either the FMT or a placebo, with extensive screening of donor microbiomes. The study aims to analyze changes in the intestinal microbiome and corresponding plasma levels of harmful metabolites over a 12-month period. The ultimate goal is to identify beneficial bacteria that could lead to a new therapeutic approach for treating atherosclerosis.
Who should consider this trial
Good fit: Ideal candidates are patients with severe unexplained atherosclerosis who meet specific inclusion criteria.
Not a fit: Patients with moderate to severe renal failure, cancer, or other serious conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment for patients with unexplained atherosclerosis by restoring a healthy gut microbiome.
How similar studies have performed: While the approach of using FMT is gaining traction, this specific application for unexplained atherosclerosis is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
London, Ontario
- Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute — London, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: J. David Spence, M.D. — Western University, Canada
- Study coordinator: J. David Spence, M.D.
- Email: dspence@robarts.ca
- Phone: 1-519-931-5731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atherosclerosis, Intestinal Microbiome