[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602206":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":41,"locations":36,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":36,"enrollmentInfo":64,"targetDuration":36,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":77,"overallStatus":82,"whyStopped":36,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":36},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"FECAL MICROBIOTA TRANSPLANTATION (with vancomycin short pretreatment phase)","EXPERIMENTAL","Participants receive oral vancomycin (125 mg QID) for 5 days (extendable to 10 if needed), followed by FMT. On Day 6, bowel cleansing is performed (macrogol-based), and biological samples (stool, blood, urine, saliva) are collected. On Day 7, FMT is administered via preferred oral capsules or, if necessary, colonoscopy, gastroscopy, NJ tube, or rectal enema. A second FMT is given either as daily capsules on Days 9-14 or as a single dose via other routes on Day 14. Dosing: 6 jars of capsules or 200 mL suspension (≥35 kg); half for \\\u003C35 kg. Supportive measures include antiemetics and fasting. Oral non-antibiotic medications continue. Post-FMT samples are collected for follow-up analyses.",[13],"Other: FMT (fecal microbiota transplantation)",{"label":15,"type":10,"description":16,"interventionNames":17},"ANTIBIOTICS ONLY - FIDAXOMICIN","Participants receive fidaxomicin 200 mg twice daily for 10 days. Biological samples (stool, blood, urine, saliva) are collected at baseline (before first antibiotic dose) for microbiome and safety analyses (PRE ATB). No additional interventions are applied. The antibiotic eradication phase ends on Day 10, after which the participant enters the follow-up phase. Post-treatment biological samples are collected (POST ATB) to assess treatment response, recurrence risk, and microbiota changes.",[18],"Drug: Fidaxomicin",{"label":20,"type":10,"description":21,"interventionNames":22},"ANTIBIOTICS ONLY - VANCOMYCIN","Participants receive vancomycin 125 mg four times daily for 10 days. Biological samples (stool, blood, urine, saliva) are collected prior to the first dose (PRE ATB) for safety and exploratory analyses. No additional therapies are administered. The eradication procedure is completed on Day 10, followed by a post-treatment sampling phase (POST ATB) for assessment of recurrence, clinical response, and microbiome status.",[23],"Drug: Vancomycin (VAN) treatment",[25,31,37],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"FMT (fecal microbiota transplantation)","This intervention consists of a two-phase treatment for Clostridioides difficile infection in high-risk adults. First, participants receive a short-course (5 days) of oral vancomycin to reduce C. difficile bacterial load. Following antibiotic pretreatment, fecal microbiota transplantation (FMT) is administered to restore healthy gut microbiota. FMT is delivered primarily via encapsulated microbiota capsules, with alternative routes including colonoscopy, gastroscopy, nasojejunal tube, or rectal enema if capsules are contraindicated. A second FMT dose is given 7 days after the first, either as daily capsules over six days or as a single endoscopic administration. This approach aims to reduce CDI recurrence by combining targeted antibiotic reduction of pathogens with microbiome restoration.",[9],[30],"Vancomycin short-course pretreatment",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Fidaxomicin","Participants receive a 10-day course of fidaxomicin administered orally at a dose of 200 mg twice daily. Fidaxomicin is a narrow-spectrum macrocyclic antibiotic specifically targeting Clostridioides difficile with minimal impact on the normal gut microbiota. This monotherapy aims to eradicate C. difficile infection while preserving the intestinal microbiome, thereby reducing the risk of recurrence. No additional interventions are provided during the treatment period. Biological samples are collected before and after treatment to evaluate clinical response, safety, and microbiome changes.",[15],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Vancomycin (VAN) treatment","Participants receive a 10-day course of oral vancomycin at a dose of 125 mg four times daily. Vancomycin is a broad-spectrum glycopeptide antibiotic commonly used as standard-of-care therapy for Clostridioides difficile infection. This monotherapy aims to eradicate C. difficile by reducing bacterial load in the colon. No additional interventions are applied during the treatment period. Biological samples are collected before and after treatment to monitor clinical outcomes, safety, and changes in the gut microbiome.",[20],[42],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Jaroslaw Bilinski, MD PhD, Assoc. Prof.","CONTACT","884 299 668","+48","jaroslaw.bilinski@human-biome.com",{"type":49,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[51],{"name":52,"class":53},"Human Biome S.A.","UNKNOWN","100602206","stop-cdi-efficacy-of-fecal-microbiota-transplantation-vs-fidaxomicin-vs-vancomycin-in-treating-and-preventing-relapse-of-clostridioides-difficile-infection-100602206",false,"NCT07120490","STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection","Multicenter, Randomized, Open-label, Three-arm Study on the Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in the Treatment and Relapse Prophylaxis of Clostridioides Difficile Infection. STOP-CDI Study","STOP-CDI","Inclusion Criteria:\n\n* Individuals aged 65 years or older OR individuals aged 18 to 64 years who meet at least one of the following criteria:\n* Presence of at least two comorbid chronic diseases from the groups of cardiovascular diseases, respiratory system diseases, gastrointestinal diseases, autoimmune diseases, cancers, chronic kidney and genitourinary diseases, immunodeficiencies, diabetes, and metabolic diseases,\n* Previous episodes of CDI,\n* Healthcare-associated CDI and\u002For hospitalization within the last three months,\n* Concurrent use of antibiotics other than CDI treatment after CDI diagnosis,\n* Use of proton pump inhibitors (PPIs) started during or after CDI diagnosis.\n* Documented Clostridioides difficile infection, defined according to ESCMID as:\n\nDiagnosis of diarrhea associated with C. difficile defined by:\n\n* \\> 3 unformed stools (or \\>200 ml of unformed stool in patients with stool collection devices) within 24 hours before randomization AND\n* Clinical signs consistent with CDI and microbiological evidence of free C. difficile toxins in an enzyme immunoassay (EIA) without justified evidence of another cause of diarrhea OR\n* Clinical picture consistent with CDI and positive nucleic acid amplification test (NAAT; PCR) preferably with low cycle threshold (Ct) value, or positive toxigenic C. difficile culture OR\n* Pseudomembranous colitis diagnosed during endoscopy or colectomy combined with a positive test for toxigenic C. difficile.\n* No more than 24 hours of prior treatment with vancomycin, metronidazole, or fidaxomicin.\n* Absolute neutrophil count in peripheral blood within 3 days before intervention \\> 500\u002Fµl.\n* Ability to swallow large capsules (using test capsules) or no contraindications for FMT via nasojejunal tube, gastroscopy, colonoscopy, or rectal enema.\n* Provided informed consent for participation in the clinical study.\n\nExclusion Criteria:\n\n* Lack of consent to participate in the study or absence of logical contact without possibility of obtaining consent from an authorized person,\n* More than 24 hours of prior treatment with vancomycin, metronidazole, or fidaxomicin,\n* On the day of inclusion (up to 3 days before starting intervention) absolute neutrophil count in blood \\\u003C500 cells\u002Fµl or expected drop to this level within the next 2 days,\n* Diagnosed HIV infection with CD4 lymphocyte count \\\u003C250 cells\u002Fµl,\n* Inability to swallow large capsules (failed test capsule use) or contraindications for FMT via upper or lower gastrointestinal tract, including gastrointestinal perforation, anal atresia, discontinuity of the gastrointestinal tract, and others,\n* Known presence of other pathogens in stool known to cause diarrhea,\n* Life expectancy \\\u003C3 months,\n* Life-threatening CDI (fulminant at diagnosis - especially with septic shock),\n* Total or subtotal colectomy, ileostomy, or colostomy,\n* Unwillingness or inability to comply with protocol requirements, including any condition (physical, mental, or social) that may affect the participant's ability to adhere to the protocol.","ALL","18 Years",{"count":65,"type":66},424,"ESTIMATED","INTERVENTIONAL",[69],"NA","The STOP-CDI study is a multicenter, randomized, open-label, three-arm clinical trial comparing the efficacy of fecal microbiota transplantation (FMT) preceded by vancomycin, fidaxomicin monotherapy, and standard-of-care vancomycin in preventing recurrence of Clostridioides difficile infection (CDI) in high-risk adult patients.\n\nCDI is a common healthcare-associated infection with rising incidence and high recurrence rates, particularly in elderly and immunocompromised individuals. While current guidelines recommend fidaxomicin as first-line therapy, its availability and reimbursement remain limited in some healthcare systems. FMT, although effective, is not widely implemented as first-line treatment. This study addresses the need for comparative, real-world data to inform treatment decisions for patients at high risk of severe or recurrent CDI.\n\nEligible participants include adults aged ≥65 years or younger patients with specific risk factors such as multiple comorbidities, prior CDI episodes, recent hospitalization, use of non-CDI antibiotics, or PPI therapy. Participants will be randomized in a 2:1:1 ratio to one of three treatment arms: (1) vancomycin plus FMT, (2) fidaxomicin, or (3) vancomycin alone. FMT is administered via capsules or, if necessary, alternative endoscopic routes.\n\nThe primary endpoint is CDI recurrence within 12 weeks following the initial treatment. Secondary endpoints include clinical cure, safety, and global cure. Exploratory analyses will assess microbiome changes and potential genomic predictors of response. A total of 424 participants will be enrolled across 10 clinical sites in Poland.\n\nThe study aims to provide robust, comparative evidence to support clinical guidelines and improve outcomes for patients with CDI, particularly in healthcare systems with limited access to novel therapies.",[72,73,74,75,33,76],"Clostridioides Difficile Infection","Clostridioides Difficile Infection Recurrence","Fecal Microbiota Transplantation (FMT)","Comparative Effectiveness of CDI Treatments","Vancomycin",[78,79,80,33,76,81],"Clostridioides difficile","CDI","Fecal microbiota transplantation","Recurrent infection","NOT_YET_RECRUITING","2025-08-06",{"date":85,"type":86},"2025-08-13","ACTUAL",{"date":88,"type":66},"2025-10",{"date":90,"type":66},"2027-04-30",{"name":5,"class":6}]