[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clostridia-difficile-colitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clostridia-difficile-colitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100618234","phase-3-vancomycin-taper-to-prevent-recurrent-clostridioides-difficile-100618234",false,"NCT07328971","Vancomycin Taper to Prevent Recurrent Clostridioides Difficile","Initial Vancomycin Taper for the Prevention of Recurrent Clostridioides Difficile Infection 2: A Randomized Controlled Trial","TAPER-V2","Inclusion Criteria\n\n1. Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.\n2. First episode or first recurrence of CDI (i.e., second episode within 120 days) defined by a positive C. difficile assay (including PCR toxin gene detection, toxin enzyme immunoassay, and\u002For cell cytotoxicity neutralization assay) and the presence of either ≥3 unformed stools in \\\u003C24 hours with a duration \\>24 hours, endoscopic\u002Fhistologic evidence of pseudomembranous colitis, or ileus. For eligibility, CDI will be considered a first recurrence if the patient experiences 2 episodes within a 120-day timeframe; those with a first ever episode, or 2 episodes separated by more than 120 days, will be categorized as a first-episode.\n\nClinical Exclusion Criteria\n\n1. Treatment with CDI-active antibiotics that will be continued throughout the trial (i.e., rifaximin for hepatic encephalopathy).\n2. Planned or current treatment of the present episode of CDI with FMT, intravenous immunoglobulins, or other microbiome therapies (i.e., VOWST or REBYOTA).\n3. Inability to take medications orally.\n4. Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.\n5. Severe intolerance or allergy to oral vancomycin or fidaxomicin.\n6. The patient is being admitted to a palliative care ward or is anticipated to die within 3 months of enrollment from another illness.\n7. Fulminant CDI, defined according to the IDSA definition of CDI with the presence of hypotension, shock, ileus, and\u002For toxic megacolon.\n8. Receipt of more than 72 hours of off-study fidaxomicin or vancomycin CDI therapy for the current episode of CDI.\n9. Pregnancy or planning to become pregnant during the study period because minimal data on fidaxomicin in pregnancy are available.\n10. Active breastfeeding because minimal data on fidaxomicin in breastfeeding are available.\n11. Patients who have had ≥3 episodes of CDI in the last 1 year.\n12. Treating team declined participation.\n13. Prior enrolment in TAPER-V2.\n\nAdministrative Exclusion Criteria\n\n1. Prior enrollment in this trial.\n2. Inability to consent without a healthcare proxy.\n3. Lack of health insurance.\n4. Anticipated transfer to a site not involved in this trial, or to a palliative care ward\n5. Patient-declared anticipated inability to participate in study follow-up or lack of means for contact in the outpatient setting.","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Indirect evidence from network meta-analyses of randomized controlled trials (RCTs) suggest that a pulse and taper (P-T) of vancomycin may be non-inferior to 10-days of fidaxomicin for the prevention of recurrent Clostridioides difficile infections (rCDI). The aim of this trial is:\n\n1\\) For first episodes and first recurrences of CDI, to test whether a vancomycin P-T is non-inferior to 10-days of fidaxomicin for the prevention of rCDI at 56 days",[27],"Clostridia Difficile Colitis",[29,30,31,32],"Clostridoides difficile","Recurrent Clostridioides difficile","C. difficile","Clostridium difficile","RECRUITING","2026-06-19",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2026-04-24",{"date":41,"type":21},"2030-11-01",{"name":43,"class":44},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":5},"100385980","phase-2-alanyl-glutamine-supplementation-for-c-difficile-treatment-act-100385980","NCT04305769","Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)","Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection: a Randomized, Double-blind, Placebo-controlled Trial","ACT","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 years and older.\n4. Admitted to UVA hospital, or seen as an outpatient, or seen at Carilion hospital.\n5. Presence of diarrhea\\*\n6. Episode of C. difficile infection, non-severe or severe uncomplicated.\n7. Within 120 hours of receiving standard therapy (oral vancomycin or fidaoxmicin).\n8. Must be able to provide informed consent in person or electronically, or if not able to have a LAR to provide consent, in person or remotely via virtual or electronic means.\n\nExclusion Criteria:\n\n1. At enrollment, presence of any of the following:\n\n   1. Hypotension or shock\n   2. Megacolon or moderate to severe ileus\n   3. Acute abdomen\n   4. Admission to intensive care unit\n2. Inability to tolerate oral or enteral medication\n3. Presence of other known infectious etiology of diarrhea\n4. COVID-19 co-infection at the time of CDI diagnosis.\n5. Absolute neutrophil count \\\u003C500 mcl\n6. Within 100 days of hematologic or solid organ transplant\n\n   • Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or other etiology of non-infectious diarrhea. For patients with history of IBD, allow enrollment if disease is well-controlled and stable (not in flare).\n7. Enrollment in another investigational drug trial\n8. Current use of alternative treatment for CDI (e.g. antibiotics other than vancomycin or fidaxomicin; IVIg; fecal transplant).\n9. On probiotics and not willing to discontinue.\n10. Cirrhosis or in participants with ALT \\> 3X normal\n11. End stage renal disease, unless on dialysis(HD or PD) or creatinine clearance or estimated GFR of \\\u003C30mL\u002Fmin even after adequate hydration\n12. Life expectancy of \\\u003C 6 months.","105 Years",{"count":56,"type":21},260,[58],"PHASE2","This is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident cases of uncomplicated C. difficile infection (CDI) in hospitalized, or outpatient, persons aged 18 or older. The investigators hypothesis is that alanyl-glutamine supplementation will decrease recurrence and mortality from CDI and these outcomes will be associated with improvement of inflammatory markers and restoration of intestinal microbiota function.",[61,62,63,27],"Clostridioides Difficile Infection","Clostridium Difficile Infection","Clostridium Difficile Diarrhea","2024-10-22",{"date":66,"type":37},"2024-10-26",{"date":68,"type":37},"2021-06-01",{"date":70,"type":21},"2027-06-30",{"name":72,"class":44},"University of Virginia"]