Recruiting
Phase 1

Observational Study

Sponsor:

Western University, Canada

Code:

NCT04410003

Conditions

Atherosclerosis

Intestinal Microbiome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fecal microbial transplant

Study Details

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 (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

Atherosclerosis

Intestinal Microbiome

Study ID

NCT04410003

Start date

Jun 2, 2020

Status verified date

Oct, 2024

Completion date

Jul 30, 2025

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Cellulose capsules, cloxacillin, electrolyte purgative (Peglyte)

active comparator: Active

Capsules of stool from Protected donors, cloxacillin, electrolyte purgative (Peglyte)

Interventions

Fecal microbial transplant

Fecal microbial transplant

Primary outcome measure

  • Changes in plasma levels of metabolites of the intestinal microbiome [ Time Frame: 6 weeks and 12 months ]
  • Metagenomic changes of the intestinal microbiome [ Time Frame: 6 weeks and 12 months ]

Central Contacts and Locations

Central contacts

J. David Spence, M.D.

1-519-931-5731dspence@robarts.ca

Leslie Paddock, R.N.

1-519-931-5731leslie.paddock@lhsc.on.ca

Locations

Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute

Recruiting

London, Ontario, Canada, N6G 2V4

Contacts

J. David Spence, M.D.

1-519-931-5731dspence@robarts.ca

More Information

Sponsor

Western University, Canada

Last update posted

Oct 17, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2024-10-17.