[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520592":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":67,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Tata Memorial Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rifaxmin +aHSCT","EXPERIMENTAL","drug rifaximin 200 mg tablet form orally twice daily (with or without food) from day-8 of transplant to day + 60 of transplant",[13],"Drug: Rifaximin 200Mg Tab",{"label":15,"type":16,"description":17,"interventionNames":18},"aHSCT alone","ACTIVE_COMPARATOR","control arm will underwent allogenic hematopoietic stem cell transplantation procedure as per standard of care",[19],"Procedure: allogenic hematopoietic stem cell transplantation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Rifaximin 200Mg Tab","Drug rifaximin 200 mg tablet form orally twice daily (with or without food) from day-8 of transplant to day + 60 of transplant",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","allogenic hematopoietic stem cell transplantation","Control arm will undergo allogenic hematopoietic stem cell transplantation as standard of care",[15],[33],{"name":34,"affiliation":35,"role":36},"Dr. Anant Gokarn, Gokarn","Advanced Centre for Treatment, Research and Education in Cancer","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Dr. Anant Gokarn, DM","CONTACT","+91-02268735000","8685","anantgokarn@gmail.com",{"name":45,"role":40,"phone":41,"phoneExt":42,"email":46},"Dr.Sumeet Mirgh, DM","drsumeetmirgh@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Actrec Tmc","RECRUITING","Navi Mumbai","Maharashtra","410210","India","IN",{"type":57,"coordinates":58},"Point",[59,60],73.01582,19.03681,{"lat":60,"lon":59},[63,65],{"name":64,"role":40,"phone":26,"phoneExt":26,"email":43},"Anant Gokarn, DM",{"name":66,"role":40,"phone":26,"phoneExt":26,"email":43},"Sumeet Mirgh, DM",{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100520592","phase-2-effect-of-rifaximin-on-gut-bacterial-flora-post-stem-cell-transplant-in-patients-with-acute-leukemia-100520592",false,"NCT06058572","Effect of Rifaximin on Gut Bacterial Flora Post Stem Cell Transplant in Patients With Acute Leukemia","Randomized Trial to Study the Effect of Rifaximin on Gut Microbiome Diversity Post Allogeneic Stem Cell Transplant in Acute Leukemia.","Inclusion Criteria:\n\n* Adults with acute leukemia undergoing allogeneic stem cell transplant.\n* ECOG performance status 0, 1 or 2.\n* Adequate Liver function\n\nExclusion Criteria:\n\n* Known hypersensitivity to rifaximin or other rifampicin antimicrobial agents\n* Current or past history of inflammatory bowel disease\n* History of major bowel resection or presence of colostomy.\n* Ongoing Verapamil, ketoconazole or itraconazole.","ALL","18 Years","70 Years",{"count":80,"type":81},166,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","* Goal: This study is a randomized phase II interventional study. The purpose of this study is to see if addition of oral rifaximin tablets during allogeneic stem cell transplant can improve the quality of gut microbiome and reduce chances of death, infections and graft versus host disease (GVHD) post-transplant.\n* The study objectives are as follows:\n* Primary Objective: To determine the impact of rifaximin on gut microbial diversity and compare it with controls.\n* Secondary Objectives: a. To determine non-relapse mortality at 1-year post transplant in patients who receive peri-transplant transplant rifaximin and compare it with controls.\n* b. To compare the incidence of severe GVHD in patients who receive peri-transplant rifaximin with the controls.\n* c. To determine impact of gut decontamination with rifaximin on incidence of MDR sepsis and usage of higher antibiotics (e.g. Carbapenems, colistin, tigecycline, ceftazidime avibactum and ceftriaxone-sulbactam EDTA) in first 6 months post BMT.\n* d. To determine the impact of rifaximin induced gut manipulation on immune reconstitution, T cell repertoire post-transplant and cytokine profile.\n* Exploratory objective: To use single cell transcriptomics (SCT) to identify immune cell profile in gut biopsies post allogeneic stem cell transplant whenever biopsy is done, to correlate the impact of microbiome on gut immunity.\n* Intervention: Tab Rifaximin 200 mg will be given orally twice daily from day -8 to day +60 of allogeneic stem cell transplant in acute leukemia patients. This will be in addition to standard of care post-transplant treatment.\n* Comparator Agent: Standard of care treatment including standard anti GVHD measures, antibiotic support and transfusions as needed.",[87],"Acute Leukemia",[89,90],"Rifaximin","Gut Microbiome","2025-07-30",{"date":93,"type":94},"2025-07-31","ACTUAL",{"date":96,"type":94},"2024-08-02",{"date":98,"type":81},"2027-08-02",{"name":5,"class":6},1]