[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498950":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":60,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Donor Fecal Microbiota Transplantation Group","EXPERIMENTAL","Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor",[13],"Biological: Donor Fecal Microbiota Transplantation",{"label":15,"type":16,"description":17,"interventionNames":18},"Autologous Fecal Microbiota Transplantation Group","PLACEBO_COMPARATOR","Subjects will receive a fecal microbiota transplantation (FMT) using their own stool",[19],"Biological: Autologous Fecal Microbiota Transplantation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Donor Fecal Microbiota Transplantation","Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Autologous Fecal Microbiota Transplantation","Single fecal microbiota transplantation using 50 gm of stool collected from the same individual",[15],[32],{"name":33,"affiliation":5,"role":34},"Madhusudan Grover, MBBS","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Jonah Pedelty, MS","CONTACT","507-538-7774","pedelty.jonah@mayo.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Margaret Breen-Lyles","507-422-5759","breen-lyles.margaret@mayo.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":26},"Mayo Clinic in Minnesota","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-92.4699,44.02163,{"lat":58,"lon":57},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Madhusudan (Madhu) Grover, MBBS","Regulatory Sponsor and Principal Investigator","100498950","phase-2-fecal-microbiota-transplantation-for-ibs-100498950",false,"NCT05776914","Fecal Microbiota Transplantation for IBS","Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)","Inclusion Criteria:\n\n* IBS defined by Rome IV criteria\n* Non IBS-C\n* Moderate to severe symptoms defined by IBS-SSS≥175\n* Able to safely undergo and consent to colonoscopy\n\nExclusion Criteria\n\n* Immune deficiency or treatment with immunosuppressive medications\n* Severe bowel or medical disease precluding administration of bowel prep\n* Severe bowel or medical disease precluding colonoscopy with conscious sedation\n* Active cancer\n* Pregnant or lactating\n* Abdominal surgery (exception of splenectomy, partial hepatectomy, partial\u002Funilateral nephrectomy, laparoscopy, pelvic floor repair, mesh, liposuction, fundoplication, tubal ligation, gastric sleeve, oophorectomy, hernia, appendectomy, cholecystectomy, caesarean section and hysterectomy)\n* Severe psychiatric disorder (HADS-A or D\\>16), or diagnosed alcohol or drug abuse disorder\n* New probiotics or treatment with antibiotics, NSAIDs (within 4 wks prior to study entry)\n* Use of treatments known to affect colonic motility (with exception of loperamide)\n* Diagnosed h\u002Fo bleeding disorder\n* Organic GI diseases (IBD, celiac disease, microscopic colitis)\n* Chronic kidney or liver disease\n* Absolute neutrophil count (ANC) \\\u003C500 IU\u002Fml","FEMALE","18 Years","70 Years",{"count":75,"type":76},43,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.",[82,83],"Irritable Bowel Syndrome","Diarrhea",[85,86],"Post-infection irritable bowel syndrome with diarrheal","Post-infection irritable bowel syndrome with mixed symptoms","2026-05-06",{"date":89,"type":90},"2026-05-08","ACTUAL",{"date":92,"type":90},"2024-04-15",{"date":94,"type":76},"2027-06-26",{"name":62,"class":6},1]