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Microbiome Therapy

Fecal Microbial Transplant for Atherosclerosis

Phase 1
Recruiting
Led By J. David Spence, M.D.
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Severe atherosclerosis, with total plaque area in the top quartile (>119 mm2), not explained by traditional risk factors in linear regression (residual score >= 2)
Be older than 18 years old
Must not have
Patients with moderate to severe renal failure (eGFR<50)
Patients with unstable angina
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks and 12 months

Summary

"This trial aims to treat patients with unexplained severe atherosclerosis by giving them fecal transplants from patients with a Protected phenotype. The goal is to see how this affects the intestinal microbiome and

Who is the study for?
This trial is for people with severe atherosclerosis, where plaque buildup in arteries isn't due to usual risk factors. Participants should have a high amount of plaque (top 25%) and not fit the typical profile for heart disease as assessed by doctors.
What is being tested?
The study tests if fecal microbial transplants from individuals resistant to artery plaque can improve gut bacteria in those with unexplained atherosclerosis, potentially lowering harmful metabolites like TMAO.
What are the potential side effects?
Potential side effects may include digestive discomfort, changes in bowel habits, and abdominal pain. There's also a risk of infection transmission through the transplant material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe artery blockage not caused by common risk factors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is low (eGFR<50).
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I have unstable chest pain.
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I am scheduled for a procedure to improve blood flow in my carotid artery.
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I am willing to take stool capsules at the start of the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in plasma levels of metabolites of the intestinal microbiome
Metagenomic changes of the intestinal microbiome

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Capsules of stool from Protected donors, cloxacillin, electrolyte purgative (Peglyte)
Group II: PlaceboPlacebo Group1 Intervention
Cellulose capsules, cloxacillin, electrolyte purgative (Peglyte)

Find a Location

Who is running the clinical trial?

Western University, CanadaLead Sponsor
253 Previous Clinical Trials
58,472 Total Patients Enrolled
1 Trials studying Atherosclerosis
100 Patients Enrolled for Atherosclerosis
European Bioinformatics InstituteUNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled
Chrysi Bogiatzi, M.D.Study DirectorDivision of Neurology, Western University
~12 spots leftby Jul 2025
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