NCT04410003 Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis
| NCT ID | NCT04410003 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Western University, Canada |
| Condition | Atherosclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-06-02 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2020-06-02 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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).
Contact & Investigator
J. David Spence, M.D.
PRINCIPAL INVESTIGATOR
Western University, Canada
Frequently Asked Questions
Who can join the NCT04410003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atherosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04410003 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04410003 currently recruiting?
Yes, NCT04410003 is actively recruiting participants. Contact the research team at dspence@robarts.ca for enrollment information.
Where is the NCT04410003 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT04410003 clinical trial?
NCT04410003 is sponsored by Western University, Canada. The principal investigator is J. David Spence, M.D. at Western University, Canada. The trial plans to enroll 100 participants.