[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561684":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":25,"responsibleParty":44,"collaborators":46,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":81,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":25},{"fullName":5,"class":6},"Hamilton Health Sciences Corporation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal Microbiota Transplant","ACTIVE_COMPARATOR","Banked donor stools that have been previously screened, prepared and frozen per previous protocols will be used to prepare all oral FMT capsules (OFC) through the laboratory of a collaborator. Recipients will receive OFC (two capsules, twice a day, twice per week) prepared from a single donor throughout their 8-week treatment course, to support assessment of FMT engraftment in recipients; this totals to 64 capsules across the duration of the study. Each OFC will contain approximately 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule.",[13],"Biological: Fecal Microbiota Transplant",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Matching oral placebo capsules (OPC) containing methylcellulose will be identical in terms of size, colour, taste, and dosing. Participants will be asked to take the Placebo treatment capsules twice a day for two days per week for a duration of eight weeks (total 64 capsules).",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","An investigational biologic comprised of 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule, to be taken twice per day, twice per week over an 8-week duration.",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"DRUG","Oral placebo capsules (OPC) containing methylcellulose, to be taken twice per day, twice per week over an 8-week duration.",[15],[31],{"name":32,"affiliation":5,"role":33},"Jennifer L Couturier, MD, MSc","PRINCIPAL_INVESTIGATOR",[35,40],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","905-521-2100","76035","coutur@mcmaster.ca",{"name":41,"role":36,"phone":37,"phoneExt":42,"email":43},"Nikhil Pai, MD","73587","pain@mcmaster.ca",{"type":45,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[47,49],{"name":48,"class":6},"McMaster University",{"name":50,"class":6},"Hamilton Academic Health Sciences Organization","100561684","fecal-microbiota-transplant-for-anorexia-nervosa-100561684",false,"NCT06593366","Fecal Microbiota Transplant for Anorexia Nervosa","A Pilot Feasibility Randomized Controlled Trial of Fecal Microbiota Transplant for Adolescent Anorexia Nervosa","FMT-AN","Inclusion Criteria: All study subjects will have been diagnosed with AN (restricting type or binge eating\u002Fpurging type) by the primary physician on the ED team, as per standard approach. Study participants will:\n\n* Be 12-17 years-old at time of recruitment\n* Have capacity to consent\n* Be assigned female sex at birth (may be gender diverse)\n* Be active patients in the pediatric ED program at MCH\n* Have a weight that is \\\u003C85% of the Treatment Goal Weight, as determined by the treating physician\n\nExclusion Criteria: Potential study subjects will be excluded due to the following reasons:\n\n* Exposure to antibiotics within two weeks of study randomization\n* Initiation of new probiotics \u002F oral nutritional supplements within two weeks of randomization\n* Active pregnancy\n* Active psychosis or suicidal ideation\n* Other comorbidities that may affect weight or the gut microbiome including celiac disease, inflammatory bowel disease (or other conditions as determined by the study team)","FEMALE","12 Years","17 Years",{"count":63,"type":64},20,"ESTIMATED","INTERVENTIONAL",[67],"NA","The purpose of this pilot randomized-controlled trial is to determine whether Fecal Microbiota Transplant (FMT) treatment demonstrates feasibility, acceptability, and prelinary effectiveness among patients with anorexia nervosa (AN). Specifically, the investigators aim to compare changes in weight, gut microbiome, urine, blood biomarkers and mood symptoms between participants receiving the FMT intervention and placebo.",[70,71,72,73,74],"Anorexia Nervosa Restricting Type","Anorexia Nervosa","Anorexia in Adolescence","Anorexia in Children","Anorexia",[76,77,78,79,80],"anorexia nervosa","fecal microbiota transplant","pilot study","randomized controlled trial","feasibility","NOT_YET_RECRUITING","2026-05-22",{"date":84,"type":85},"2026-05-27","ACTUAL",{"date":87,"type":64},"2026-06-01",{"date":89,"type":64},"2027-06-01",{"name":5,"class":6}]