Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern University, Canada
About this trial
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
This trial does not accept healthy volunteersQualifiers
Severe atherosclerosis, with total plaque area in the top quartile (>119 mm2), not explained by traditional risk factors in linear regression (residual score >= 2)
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Fecal microbial transplant
Biological/VaccineFecal microbial transplant
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: ActiveActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in plasma levels of metabolites of the intestinal microbiome
The primary outcome is changes in plasma levels of trimethylamine N-oxide and p-cresylsulfate
Time frame
6 weeks and 12 months2
Metagenomic changes of the intestinal microbiome
Metagenomic changes in the stool of transplant recipients will be analyzed to determine what changes in the intestinal bacteria are associated with changes in the plasma levels of the intestinal metabolites.
Time frame
6 weeks and 12 monthsSponsors and contacts
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Western University, Canada
Lead sponsor
European Bioinformatics Institute
Collaborator
Source ClinicalTrials.gov