[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clostridioides-difficile-infection-recurrence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clostridioides-difficile-infection-recurrence":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,52,80,111,137,162],{"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":26,"conditions":27,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100591375","phase-2-secondary-prevention-of-clostridioides-difficile-using-vancomycin-100591375",false,"NCT06979609","Secondary Prevention of Clostridioides Difficile Using Vancomycin","Secondary Prophylaxis of Recurrent Clostridioides Difficile Infections During Systemic Antibiotics With Vancomycin: A Randomized Controlled Trial","SPORES-V","Inclusion Criteria\n\n1. Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.\n2. An episode of CDI within the preceding 120 days, diagnosed by both 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.\n3. Treatment of the qualifying CDI episode with vancomycin or fidaxomicin for ≥10 days, and achievement of clinical cure (≤3 unformed stool per 24 hours in ≥2 days10).\n4. Receipt of ≤3 days of at least one oral or intravenous systemic antibiotic, for which therapy is planned for at least one additional consecutive day in duration.\n\nClinical Exclusion Criteria\n\n1. ≥72 hours of off-study vancomycin prophylaxis for the current episode of antibiotic re-exposure.\n2. ≤1 day elapsed since discontinuation of CDI treatment\n3. Treatment of the qualifying episode of CDI with metronidazole monotherapy or intravenous immunoglobulins.\n4. Planned treatment with or treatment of the qualifying episode of CDI with fecal microbiota transplantation (FMT), bezlotoxumab, VOWST, REBYOTA, or another microbiome agent.\n5. Inability to take medications orally.\n6. Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.\n7. Severe intolerance or allergy to oral vancomycin.\n8. Lack of achievement of clinical cure during the treatment of the qualifying CDI episode\n9. The qualifying antibiotic is solely for prophylaxis (e.g., once daily trimethoprim sulfamethoxazole) or the patient is anticipated to require systemic antibiotics for \\>4 weeks (e.g., lifelong suppressive therapy or for the treatment of left-sided endocarditis or a deep-seated abscess).\n10. Patients on ongoing systemic antibiotics since the completion of treatment for the qualifying episode of CDI that have not been interrupted by at least one day.\n11. Patients admitted to a palliative care ward or who are anticipated to die within 8 weeks of enrollment from another illness.\n12. The qualifying antibiotic is non-systemic (i.e., topical) or is not considered a significant risk factor for CDI including: single-dose antibiotics, as well as macrolides, nitrofurantoin, intravenous vancomycin, metronidazole, tetracyclines, and oral fosfomycin. If two or more systemic antibiotics are given (i.e., ceftriaxone and azithromycin), as long as at least one of the systemic antibiotics does not meet exclusion criteria, then the patient will still be eligible.\n13. Concomitant receipt of rifaximin (e.g., for hepatic encephalopathy).\n14. Receipt of ≥2 courses of vancomycin prophylaxis since the qualifying episode of CDI or \\\u003C2 weeks since the last course of vancomycin prophylaxis.\n15. Treating team declined participation.\n\nAdministrative Exclusion Criteria\n\n1. Prior enrollment in this trial.\n2. Inability to consent and 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},300,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Re-exposure to systemic antibiotics (i.e., antibiotics absorbed into the bloodstream) is common after a Clostridioides difficile infection (CDI) and is the strongest risk factor for a recurrent episode. Oral vancomycin to prevent a recurrence during antibiotic re-exposure may reduce this risk but the data supporting this practice are limited. The aim of this trial is:\n\n1\\) Does oral vancomycin prophylaxis prevent CDI recurrences in patients with recent CDI (within 120 days) and who are re-exposed to systemic antibiotics?\n\nThe trial will compare oral vancomycin to placebo.\n\nParticipants will:\n\n* Take the study drug (either vancomycin or placebo) twice daily for the duration of systemic antibiotics plus once daily for 7 days after completion of systemic antibiotics.\n* Attend an in-person or over the phone follow-up at day 56\n* Respond to weekly electronic questionnaires",[28,29,30],"Clostridioides Difficile Infection","Clostridioides Difficile Infection Recurrence","Clostridoides Difficile Associated Disease",[32,33,34,35,36,37,38],"Clostridioides difficile","Clostridium difficile","Vancomycin","Prophylaxis","C. difficile","Recurrence","CDI","RECRUITING","2026-06-19",{"date":42,"type":43},"2026-06-24","ACTUAL",{"date":45,"type":43},"2025-11-01",{"date":47,"type":21},"2029-10-01",{"name":49,"class":50},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100612218","c-difficile-toxin-levels-in-stool-from-healthy-individuals-following-standard-of-care-antibiotic-treatment-for-cdi-100612218","NCT07250724","C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.","A Prospective, Observational Study to Evaluate C. Difficile Toxin Levels in Stool in Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.","Participants will be included in the study if they meet all of the following criteria\n\nAt the time of screening:\n\n* Able to provide signed and dated informed consent\n* Males and females from the age of 18 and above\n* Planned or already ongoing SoC antibiotic treatment for diagnosed Clostridiodides difficile infection (CDI). All types of diagnosis\u002Ftesting algorithms, and antibiotic taper regimes acceptable.\n* Documented history of, minimum one previous CDI episode occurring within the last 12 months.\n\nAt the Time of Baseline Visit:\n\n\\- Have completed the antibiotic treatment regime for the current CDI, a maximum of 5 days prior to the baseline visit\n\nExclusion criteria\n\nParticipants will be excluded from the study if they meet any of the following criteria:\n\nAt the time of screening:\n\n* Planned CDI recurrence treatment for the planned 8-week duration of study participation (I.e., Fecal microbiome transplant, Rebyota, Vowst, Live Biotherapeutic Products (LBPs), probiotics etc)\n* Pregnant or lactating women or women who intend\u002Fwish to become pregnant in the time period in between screening and visit 4\n* Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. I.e.: Ostomized participants, Parenteral nutrition users, Patients with active Pancreatitis, Active, non-controlled intestinal diseases such as IBS, IBD, Crohn's Disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness\n* Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.\n* Individuals who, in the opinion of the investigator, are considered to be poor study attendees or unlikely for any reason to be able to comply with the study.\n* Participants may not be participating in other clinical studies, or planning to do so during participating in the present study. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.\n\nAt the time of baseline visit:\n\n* Lack of CDI symptom resolution following the SoC antibiotic regime. I.e. still active diarrhoea (3 or more stools per 24-hour period) and within Bristol stool scale range of 5-7 at baseline.\n* Those who are on, or during study participation plan to go on, antibiotic treatment for any reason.",{"count":60,"type":21},60,"OBSERVATIONAL","Hospitals and clinics interested in participating in this multi-site study, please contact the people mentioned under \"Contacts and Locations\".\n\nThe goal of this study is to map the risk of having a C. Difficile infection recurrence (rCDI) after being treated with standard-of-care antibiotics for a C. Difficile infection.\n\nThe main questions it aims to answer are:\n\n* What is the recurrence rate of CDI in the 8 weeks following antibiotic treatment for a first recurrence of CDI?\n* Does toxin levels of Toxin A and\u002For B from C. Diff. at baseline predict CDI recurrence risk?\n\nParticipants will:\n\n* Undergo standard of care Antibiotic treatment for first recurrence of CDI\n* Visit their clinic at 4 different visits over a time period of approximately 9 weeks. (Visits can also be performed remote\u002Fvia phone call.)",[29],[65,66,28,29,67,68],"C. Diff","Clostridioides Difficile","Clostridioides Difficile Recurrence","C. Diff recurrence","2026-06-12",{"date":71,"type":43},"2026-06-15",{"date":73,"type":43},"2026-03-01",{"date":75,"type":21},"2026-10-15",{"name":77,"class":78},"Bactolife A\u002FS","INDUSTRY",4,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100534332","phase-3-ve303-for-prevention-of-recurrent-clostridioides-difficile-infection-100534332","NCT06237452","VE303 for Prevention of Recurrent Clostridioides Difficile Infection","A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection","RESTORATiVE303","Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population):\n\n* Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months\n\nKey Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population):\n\n* Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI\n* OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:\n\n  1. Age ≥ 65 years\n  2. Kidney dysfunction, defined as estimated creatinine clearance \\\u003C 60 mL\u002Fmin\u002F1.73 m\\^2 at the time of the qualifying CDI episode\n  3. History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study\n  4. History of a prior CDI episode between 6 and 12 months prior to enrollment\n  5. Immunosuppression due to an underlying disease or its treatment\n  6. Has undergone solid organ or hematopoietic stem cell transplantation\n\nKey Inclusion Criteria (For enrollment in Stage 1 or 2):\n\n* The qualifying episode of CDI must meet all the following criteria:\n\n  1. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days\n  2. CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI\n  3. Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A\u002FB and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA\u002FGDH results, performed at either a local laboratory or the central laboratory\n  4. Diarrhea considered unlikely to have another etiology\n* Prior to receiving any study medication, the participant should:\n\n  1. Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration.\n  2. Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, \\\u003C 3 loose\u002Funformed bowel movements per 24 hours for at least 2 consecutive days\n* Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing\n* Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization\n\nKey Exclusion Criteria (For both Stage 1 and Stage 2):\n\n* History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI\n* Known or suspected toxic megacolon or small bowel ileus at the time of randomization\n* History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis\n* Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode\n* Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug\n* Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study)\n* Probiotics, whether characterized as a dietary\u002Ffood supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt, kombucha, and kefir are permitted.)\n* Absolute neutrophil count (ANC) of \\\u003C 0.5 ×10\\^9 cells\u002FL on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC \\\u003C 1.0 × 10\\^9 cells\u002FL","12 Years",{"count":90,"type":21},852,[25],"The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).",[94,95,96,28,29,38,97,98,99,100],"Clostridium Difficile","Clostridium Difficile Infections","Clostridium Difficile Infection Recurrence","C. Diff Infection","Recurrent Clostridium Difficile Infection","C.Difficile Diarrhea","Diarrhea Infectious","2026-05-28",{"date":103,"type":43},"2026-06-02",{"date":105,"type":43},"2024-05-20",{"date":107,"type":21},"2027-10",{"name":109,"class":78},"Vedanta Biosciences, Inc.",215,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":51},"100628234","phase-3-fmt-capsules-for-rcdi-100628234","NCT07458984","FMT Capsules for rCDI","Fecal Microbiota (FMT) Oral Capsules in the Treatment of Recurrent Clostridioides Difficile Infection","FMT CAP CDI","Inclusion Criteria:\n\n* At least twice recurrent CDI\\*\n* Patient has had CDI-related diarrhea during infections (3 or more Bristol Stool Form Scale type 6-7 stools)\n* Other causes of diarrhea have been excluded based on clinical data\n* Age over 18 years\n* Remission of symptoms during antibiotic course (metronidazole, vancomycin or fidaxomicin)\n* No other antibiotic courses\n* Able to sign the consent form or accept it electronically via Suomi.fi identification\n\n  * definition of recurrent CDI: CDI-compatible symptoms and a positive stool test Clostridioides difficile nucleic acid test within 12 weeks of the previous infection\n\nExclusion Criteria:\n\n* Pregnancy\n* Continuous need for antibiotic treatment\n* Previous anaphylactic reactions to any food\n* Gastroparesis\n* Life-threatening fulminant CDI\n* Life expectancy less than 1 year\n* Inability to sign a consent form for the study",{"count":120,"type":21},76,[25],"Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.",[29,124],"FMT",[126,124,127],"Clostridioides Difficile infection","Capsule","2026-04-24",{"date":130,"type":43},"2026-04-29",{"date":132,"type":43},"2026-04-25",{"date":134,"type":21},"2030-12-31",{"name":136,"class":50},"Helsinki University Central Hospital",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":51},"100496100","changes-in-recipients-gut-microbiota-after-fecal-microbiota-transplantation-100496100","NCT05739825","Changes in Recipients Gut Microbiota After Fecal Microbiota Transplantation","Assessment Of Changes In Gut Microbiota Of Patients With Recurrent Clostridioides Difficile Infection After Fecal Microbiota Transplantation: Prospective Study","Inclusion Criteria:\n\n* Recurrent Clostridioides difficile infection\n* Age between 18 and 90 years old\n* Ability to provide written informed consent\n* Ability to be compliant with the scheduled procedures\n\nExclusion Criteria:\n\n* Another known gastrointestinal infection apart from C. difficile infection\n\n  . Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea)\n* Previous colorectal surgery or cutaneous stoma\n* Current or recent (\\\u003C 6 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics)\n* Decompensated heart failure or heart disease with ejection fraction lower than 30%\n* Severe respiratory insufficiency\n* Psychiatric disorders\n* Pregnancy or breastfeeding\n* Unable to give informed consent","90 Years",{"count":146,"type":21},20,"Clostridioides difficile infection (CDI) is the most common cause of nosocomial diarrhea, and the most common health care-associated infectious disease in the United States, accounting for 15% of overall infections, nearly 30.000 deaths per year an estimated economic expense of $5 billion\u002Fyear.\n\nIn the last decade, most of the burden related to CDI depends on recurrence CDI (rCDI) (3). rCDI is known to extend the hospitalization length, and to be associated with increased morbidity and mortality rates.\n\nFurthermore, rCDI is often, more than primary infection, associated with life-threatening complications, including pseudomembranous colitis, toxic megacolon, shock, perforation, bloodstream infection (BSI), sepsis, caused by intestinal bacteria or fungi with a mortality rate nearly 50%, and death.\n\nFecal microbiota transplantation (FMT), defined as the infusion of feces from healthy donors to recipient with disorders associated to dysbiosis, is known to be a highly effective treatment option against CDI. FMT is also more effective than standard treatment with vancomycin and it is recommended by International Guidelines for treating multiple recurrence of CDI.\n\nDespite the increasing body of evidence about the clinical efficacy of FMT for the treatment of rCDI, mechanisms for this clinical efficacy are also unknown.\n\nMetagenomics analysis is known as a good option to examine gut microbiota and to estimate microbial diversity. The aim of this study is to evaluate changes in microbial composition in rCDI patients after FMT, using metagenomics analysis.",[29],[150,151,152],"Clostridioides difficile infection","Fecal Microbiota Trasplantation","Engraftment","2026-03-17",{"date":155,"type":43},"2026-03-19",{"date":157,"type":43},"2023-02-13",{"date":159,"type":21},"2027-02-14",{"name":161,"class":50},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":174,"conditions":175,"keywords":179,"overallStatus":182,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":4},"100602206","stop-cdi-efficacy-of-fecal-microbiota-transplantation-vs-fidaxomicin-vs-vancomycin-in-treating-and-preventing-relapse-of-clostridioides-difficile-infection-100602206","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.",{"count":171,"type":21},424,[173],"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.",[28,29,176,177,178,34],"Fecal Microbiota Transplantation (FMT)","Comparative Effectiveness of CDI Treatments","Fidaxomicin",[32,38,180,178,34,181],"Fecal microbiota transplantation","Recurrent infection","NOT_YET_RECRUITING","2025-08-06",{"date":185,"type":43},"2025-08-13",{"date":187,"type":21},"2025-10",{"date":189,"type":21},"2027-04-30",{"name":191,"class":50},"Medical University of Warsaw"]