[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03562741":3,"trial-entities:NCT03562741":81,"trial-summary:NCT03562741":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":14,"eligibility_criteria":43,"std_ages":52,"locations":56,"central_contacts":74,"overall_officials":76,"references":79,"see_also_links":80},"NCT03562741","H00003682","Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile","RECRUITING","2029-01-16","2026-02","2026-02-20","2014-01-16","Krunal Patel","OTHER",false,"The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.","Fecal microbiota transplantation (FMT) involves administering fecal material from a healthy individual into the gastrointestinal tract of the patient. This has been done in the past for recurrent colitis secondary to Clostridium difficile infection (CDI) using different methods such as through nasogastric tube, fecal retention enemas, and by colonoscopy. This method of treatment was introduced over 50 years ago with high success rates, although it has not been until recent that more case studies have been performed, with continued success rates of approximately 90%. Studies have found this therapy to be effective with resolution of symptoms in most patients, and have found it to be both cost effective and safe.\n\nThe purpose of this study is to use a standardized published protocol for fecal microbiota transplantation performed by colonoscopy and record the success rate and outcomes of FMT therapy for patients with recurrent CDI at the UMassMemorial Medical Center. In addition, the cost of this therapy will be compared to conventional antibiotic treatment. The reduction in hospitalizations will also be monitored compared with historical controls.\n\nThe hypothesis of this study is that FMT therapy will show resolution of infection in most patients with recurrent CDI, with an overall reduction in cost to the hospital for recurrent admissions for Clostridium difficile colitis as compared to historical controls. Historical controls will be defined as patients with recurrent positive Clostridium difficile stool samples treated in the traditional fashion with antibiotics.",[18,19],"Clostridium Difficile Infection Recurrence","Clostridium Difficile Infection",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},500,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","Fecal Microbiota Transplantation","Transplantation of Screened donor stool as part of Fecal Microbiota Transplantation",[31],[35],{"measure":36,"description":37,"timeFrame":38},"Clostridium Difficile (C. diff) resolution'","Longterm resolution of C. diff associated diarrhea after Fecal Microbiota Transplantation (FMT) therapy","12 months",[],"ALL","16 Years",null,{"inclusion":44,"exclusion":48,"raw_text":51},[45,46,47],"Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy.","Failed standard therapy with oral metronidazole and\u002For oral vancomycin","One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity",[49,50],"Age \\\u003C16 years old","patients with acute severe colonic dilation at risk for colonic perforation","Inclusion Criteria:\n\n* Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy.\n* Failed standard therapy with oral metronidazole and\u002For oral vancomycin\n* One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity\n\nExclusion criteria:\n\n* Age \\\u003C16 years old\n* patients with acute severe colonic dilation at risk for colonic perforation",[53,54,55],"CHILD","ADULT","OLDER_ADULT",[57],{"facility":58,"status":7,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":71},"UMass Memorial Medical Center","Worcester","Massachusetts","01655","United States",[64,68],{"name":65,"role":66,"email":67},"Anne Foley","CONTACT","Anne.Foley@umassmed.edu",{"name":69,"role":70},"Krunal Patel, MD","PRINCIPAL_INVESTIGATOR",{"lat":72,"lon":73},42.26259,-71.80229,[75],{"name":65,"role":66,"email":67},[77],{"name":12,"affiliation":78,"role":70},"UMass Medical School",[],[],{"nct_id":4,"conditions":82,"biomarkers":84},[83],"Clostridium difficile Infection",[],{"nct_id":4,"found":86,"summary":87,"prompt_version":97},true,{"design":88,"status":89,"heading":90,"summary":91,"follow_up":92,"word_count":93,"commitments":94,"compensation":95,"drugs_mentioned":96},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 500 participants.","completed","Fecal Microbiota Transplantation for Recurrent C. diff","This study is looking at how well Fecal Microbiota Transplantation (FMT) works to treat Clostridium difficile (C. diff) infections that keep coming back. FMT involves transplanting healthy donor stool into your colon, usually through a colonoscopy. The goal is to replace the good bacteria in your gut to help prevent C. diff from returning. To join, you must be at least 16 years old and have had C. diff come back two or more times. The study will measure if your C. diff infection resolves after 12 months. The current recruitment status is unclear, but the study aims to enroll 500 participants.","Your C. diff resolution will be measured at 12 months after the procedure.",102,"You would undergo a Fecal Microbiota Transplantation procedure via colonoscopy. The study will track your C. diff resolution for 12 months.","Not stated in the trial record.",[31],"v2"]