[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100393973":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":33,"locations":41,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":24,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":24,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":24,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Western University, Canada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Cellulose capsules, cloxacillin, electrolyte purgative (Peglyte)",[13],"Biological: Fecal microbial transplant",{"label":15,"type":16,"description":17,"interventionNames":18},"Active","ACTIVE_COMPARATOR","Capsules of stool from Protected donors, cloxacillin, electrolyte purgative (Peglyte)",[13],[20],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","Fecal microbial transplant",[15,9],null,[26,29],{"name":27,"affiliation":5,"role":28},"J. David Spence, M.D.","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":32},"Chrysi Bogiatzi, M.D.","Division of Neurology, Western University","STUDY_DIRECTOR",[34,38],{"name":27,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","1-519-931-5731","dspence@robarts.ca",{"name":39,"role":35,"phone":36,"phoneExt":24,"email":40},"Leslie Paddock, R.N.","leslie.paddock@lhsc.on.ca",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute","RECRUITING","London","Ontario","N6G 2V4","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-81.23304,42.98339,{"lat":54,"lon":53},[57],{"name":27,"role":35,"phone":36,"phoneExt":24,"email":37},{"type":59,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[61],{"name":62,"class":63},"European Bioinformatics Institute","UNKNOWN","100393973","phase-1-metabolic-and-metagenomic-effects-of-intestinal-microbiome-repopulation-in-unexplained-atherosclerosis-100393973",false,"NCT04410003","Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis","Metabolic and Metagenomic Effects of Repopulation of the Intestinal Microbiome in Patients with Severe Unexplained Atherosclerosis","Inclusion Criteria:\n\n* Severe atherosclerosis, with total plaque area in the top quartile (\\>119 mm2), not explained by traditional risk factors in linear regression (residual score \\>= 2)\n\nExclusion Criteria:\n\n* Excluded will be patients unwilling\u002Funable to provide informed consent, unwilling to ingest the stool capsules at baseline, patients with moderate to severe renal failure (eGFR\\\u003C50), immunosuppressed patients, and patients with cancer, unstable angina, planned carotid revascularization or other conditions that might be expected to reduce their survival to \\\u003C 1 year (including age \\>80).","ALL","18 Years",{"count":74,"type":75},100,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","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.",[81,82],"Atherosclerosis","Intestinal Microbiome","2024-10-15",{"date":85,"type":86},"2024-10-17","ACTUAL",{"date":88,"type":86},"2020-06-02",{"date":90,"type":75},"2025-07-30",{"name":5,"class":6},1]