Status:
RECRUITING
Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis
Lead Sponsor:
Western University, Canada
Collaborating Sponsors:
European Bioinformatics Institute
Conditions:
Atherosclerosis
Intestinal Microbiome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 (pa...
Detailed Description
100 patients with Unexplained Atherosclerosis, and 5 donors with the protected phenotype will be recruited; there will be extensive microbial, viral and parasitic screening of the donors. Recipients w...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04410003
Start Date
June 2 2020
End Date
July 30 2025
Last Update
October 17 2024
Active Locations (1)
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1
Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute
London, Ontario, Canada, N6G 2V4