Actively Recruiting
Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis
Led by Western University, Canada · Updated on 2024-10-17
100
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
Sponsors
W
Western University, Canada
Lead Sponsor
E
European Bioinformatics Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe atherosclerosis with total plaque area in the top quartile (>119 mm2), not explained by traditional risk factors (residual score 2)
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Unwilling to ingest stool capsules at baseline
- Moderate to severe renal failure (eGFR <50)
- Immunosuppressed patients
- Patients with cancer
- Unstable angina
- Planned carotid revascularization
- Conditions expected to reduce survival to less than 1 year, including age over 80 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute
London, Ontario, Canada, N6G 2V4
Actively Recruiting
Research Team
J
J. David Spence, M.D.
CONTACT
L
Leslie Paddock, R.N.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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