[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clostridioides-difficile-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clostridioides-difficile-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,46,80,107,136,161,191,218,248,270,294,316,342,366,388,414,450,473,492,517,541,567,592],{"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},"100614870","phase-2-prevention-of-recurrent-c-difficile-infection-study-with-azd5148-monoclonal-antibody-100614870",false,"NCT07285213","Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody","A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AZD5148 for Prevention of Recurrence of Clostridioides Difficile Infection in Individuals 18 Years of Age and Above","PRISM","Inclusion Criteria:\n\nParticipant must be ≥ 18 years of age at the time of signing the informed consent, capable of giving signed informed consent.\n\nParticipants with a qualifying C. difficile infection episode at the time of providing informed consent defined by:\n\n* Positive local C. difficile toxin test (eg, immune assay or CCNA) on an unformed stool sample collected during this episode, and\n* Receipt of standard of care antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode, with planned duration of at least 10 and at most 25 days at time of IMP administration.\n\nNote: Diarrhea is not required to be present on the day of investigational medicinal product (IMP) administration.\n\nBody weight ≥ 40 kg\n\nExclusion Criteria:\n\nHistory of inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease, microscopic colitis).\n\nParticipant with a non - CDI (C. difficile infection) condition such that the participant routinely passes loose stool (eg, patients with an ostomy)\n\nPlanned surgery for C. difficile infection within 24 hours of enrollment\n\nCurrent toxic megacolon and\u002For small bowel ileus\n\nAny history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, ie, restrictive procedures such as banding, are permitted).\n\nMajor gastrointestinal surgery as assessed by the Investigator (eg, significant bowel resection or diversion) within 90 days before enrollment (this does not include appendectomy or cholecystectomy)\n\nDue to receive more than 25 days of antibacterial drug therapy for C. difficile infection for the qualifying C. difficile infection episode\n\nTreatment with a fecal donor transplant or fecal microbiota product in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of C. difficile infection, or planned administration during the 180 days after IMP administration\n\nTreatment with bezlotoxumab in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of CDI, or planned administration during the 180 days after IMP administration.","ALL","18 Years",{"count":20,"type":21},230,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.",[27],"Clostridioides Difficile Infection",[29,30,31,32],"Clostridioides Difficile infection","C. Diff","CDiff","Clostridiodes Difficile Infection prevention of recurrence","RECRUITING","2026-06-23",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2025-12-10",{"date":41,"type":21},"2028-01-18",{"name":43,"class":44},"AstraZeneca","INDUSTRY",114,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100591375","phase-2-secondary-prevention-of-clostridioides-difficile-using-vancomycin-100591375","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.",{"count":55,"type":21},300,[24,57],"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",[27,60,61],"Clostridioides Difficile Infection Recurrence","Clostridoides Difficile Associated Disease",[63,64,65,66,67,68,69],"Clostridioides difficile","Clostridium difficile","Vancomycin","Prophylaxis","C. difficile","Recurrence","CDI","2026-06-19",{"date":36,"type":37},{"date":73,"type":37},"2025-11-01",{"date":75,"type":21},"2029-10-01",{"name":77,"class":78},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":79},"100640695","lifestyle-and-recurrent-clostridioides-difficile-infection-cdi-100640695","NCT07613645","Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)","Diet for Prevention of Recurrent C. Difficile Infection","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n* Non-recurrent non-fulminant CDI (laboratory-confirmed C. difficile infection without prior C. difficile infection within 3 months and no shock, hypotension, ileus, or megacolon)\n* Currently receiving treatment or with plan to initiate treatment for CDI\n* CDI treatment with standard regimen (fidaxomicin 200milligrams (mg) by mouth (PO) twice a day x 10-14 days or vancomycin 125mg PO 4 x a day (QID) x 10-14 days)\n* No prior advanced therapy for C. difficile (i.e. prolonged antibiotic therapy, bezlotoxumab, fecal transplant, other microbial therapy)\n\nExclusion Criteria:\n\n* Chemotherapy, immunotherapy, or transplant within 12 months\n* Colon not in continuity (i.e. status post total colectomy or with current ileostomy)\n* Medical comorbidities requiring specific fluid, sodium, or protein intake level outside range of prepared diet options\n* Baseline diet with \\> 11grams fiber\u002F1000 kilocalories\n* Low sodium diet, vegan diet, gluten-free diet, Kosher diet or any other diet not able to be accommodated by the metabolic kitchen\n* Allergies, food preferences, or other restrictions not able to be accommodated by the metabolic (note: lactose intolerance will not impact eligibility)\n* Unwilling to stop probiotic supplements during the study period\n* Current antibiotic therapy that will continue after CDI treatment has finished\n* Hospitalized or in skilled nursing facility at time of CDI treatment conclusion\n* Pregnancy or breast-feeding\n* Unable to provide a stool sample of appropriate quality for further analysis (i.e. low volume, adulterated, delayed return, etc.)",{"count":88,"type":21},20,[90],"NA","This study aims to evaluate the impact of diet on the gut microbiome in adults with Clostridioides difficile infection (CDI). Eligible participants will be randomized and receive meals plus different types of health counseling. Counseling visits will be by phone or online videoconference (e.g. Zoom). Meals will be provided for two weeks and then participants will be asked to continue similar meals for 6 more weeks.\n\nParticipants will provide responses to questionnaires and multiple stool samples over the course of the study. The goal is to understand how different health factors might impact the risk of becoming infected again with C. difficile in the future.\n\nOf note, this study will conceal the intervention details (type of diets) so that the control group does not increase their intake with the particular diet during the study. Participants in the control arm will be unblinded at the end of the study during a debrief with a member of the study team. At that time participants will be informed of diet being tested.",[27],[94,95,96,97],"Diet","Health counseling","Surveys","Stool samples","2026-06-02",{"date":100,"type":37},"2026-06-04",{"date":102,"type":21},"2026-06",{"date":104,"type":21},"2027-06",{"name":106,"class":78},"University of Michigan",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100623826","phase-1-fecal-microbiota-transplantation-in-an-expanded-ulcerative-colitis-population-100623826","NCT07401680","Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population","A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)","FRONTIER-UC","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Able to provide informed consent\n3. Established UC diagnosis through standard endoscopic and histologic criteria\n4. Active UC\n5. Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial\n6. Willing and able to comply with all required study procedures\n\nExclusion Criteria:\n\n1. Severe UC requiring hospitalization\n2. Crohn's disease or indeterminate colitis\n3. Irritable bowel syndrome\n4. Intestinal infection within 4 weeks of enrollment\n5. Evidence of toxic megacolon or gastrointestinal perforation on imaging\n6. Planned colectomy\n7. Abdominal surgery within 60 days of enrollment\n8. Neutropenia with absolute neutrophil count \\\u003C0.5 x 109\u002FL\n9. Peripheral white blood cell count \\> 35.0 x 109\u002FL and fever (\\>38C)\n10. Planned or actively taking another investigational product\n11. Uncontrolled medical conditions such as psychiatric disorders or substance abuse\n12. Severe underlying disease such that the patient is not expected to survive for at least 30 days\n13. Pregnancy or breastfeeding\n14. Unwilling to discontinue non-dietary probiotic\n15. Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study\n16. FMT for any reason within 6 months of enrollment\n17. Investigator's judgement that enrolment is not in the best interest of the patient",{"count":116,"type":21},85,[118],"PHASE1","This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.",[121,122,27],"Ulcerative Colitis","Inflammatory Bowel Diseases",[124,125,126,127],"Fecal microbiota transplantation","FMT","Lyophilized fecal microbiota transplantation","LFMT",{"date":100,"type":37},{"date":130,"type":37},"2026-03-01",{"date":132,"type":21},"2028-12-01",{"name":134,"class":78},"University of Alberta",2,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100459760","phase-3-fecal-microbiota-transplantation-in-clostridioides-difficile-infection-first-episode-and-first-recurrence-100459760","NCT05266807","Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence","Fecal Microbiota Transplantation Versus Vancomycin or Fidaxomicin in Clostridioides Difficile Infection First Episode or First Recurrence: A Randomized Controlled, Open-label, Multicenter Phase III Clinical Trial","FENDER","Inclusion Criteria:\n\n1. Adults (≥18 years old) at the time of informed consent\n2. Informed consent signature\n3. Medical record documentation of CDI defined as:\n\n   a. A first CDI episode associated with risks factors for recurrence, defined as: i. No CDI episode within the last 8 weeks ii. Current combination of CDI signs and symptoms, confirmed by medical record documentation of microbiological evidence of C. difficile toxin and C. difficile in stools shown by a CDI PCR positive test with Ct \\\u003C 25 or a toxin A\u002FB EIA positive test and without reasonable evidence of another cause of diarrhea, iii. Presenting at least one of the following risks factors for CDI recurrence:\n   * age \\>65 years-old,\n   * hospitalization within the last 3 months,\n   * use of proton pump inhibitors (PPI) within the last 3 months,\n   * Charlson comorbidity index (CCI) \\>2,\n   * living in long term facility,\n   * healthcare- associated CDI (see definition in section 7),\n   * severe CDI episode (see definitions in section 6.1.2),\n   * immunocompromised patient (except severely immunocompromised according to definitions in section 7.1),\n   * history of prior CDI episode(s) (more than 8 weeks ago). OR b. A first CDI recurrence, defined as: i. Previous episode of treated and cured CDI within the last 8 weeks confirmed by medical record documentation of a clinical picture of CDI combined with a positive microbiological CDI test performed according to CDI diagnosis ESCMID guidelines ii. Current combination of CDI signs and symptoms, confirmed by medical record documentation of microbiological evidence of C. difficile toxin and C. difficile in stools shown by a CDI PCR positive test with Ct \\\u003C 25 or a toxin A\u002FB EIA positive test , and without reasonable evidence of another cause of diarrhea..\n4. No multiple episodes (no more than 2 CDI episodes) within 3 last months.\n5. Already taking since less than 10 days or will start a course of antibiotics (vancomycin or fidaxomicin) to control recurrent CDI symptoms at the time of screening.\n6. Willing and able to have FMT by capsule\n\nExclusion Criteria:\n\n1. Severe-complicated CDI if at least one of the following signs or symptoms are:\n\n   * ongoing at time of screening and related to CDI: hypotension, septic shock, elevated serum lactate, ileus,\n   * or were present at any time of the CDI episode and related to CDI: toxic megacolon, bowel perforation, or any fulminant course of disease (i.e. rapid deterioration of the patient.\n2. Prior FMT within 6 months of randomization,\n3. Prior total colectomy, colostomy, ileostomy, or gastrectomy\n4. Metronidazole already given alone for the treatment of the current CDI for more than 3 days,\n5. Need for continued non-anti-CDI systemic antibiotics (should be stopped at randomization at the latest), except prophylactic doses of trimethoprim\u002Fsulfamethoxazole,\n6. Anticipated indication for antibiotics treatment (for a non-CDI reason) in the next 8 weeks except prophylactic doses of trimethoprim\u002Fsulfamethoxazole\n7. Other causes of chronic or acute diarrhea beyond CDI (chronic diarrhea is defined as loose\u002Fwatery stools, which occur three or more times within 24 hours and last for 4 or more weeks)\n8. Inflammatory bowel disease,\n9. Patients with swallowing disorders, Zenker's diverticulum, gastroparesis, or prior small bowel obstruction,\n10. Known hypersensitivity to vancomycin or fidaxomicin,\n11. Pregnant\u002Flactating women,\n12. Estimated patient's life expectancy of less than 10 weeks,\n13. Inability to follow protocol study procedures,\n14. Inability to give informed consent,\n15. Any condition or medications that will put the participant at greater risk from FMT according to the investigator,\n16. Severely immunocompromised\n17. No response to anti-CDI antibiotic treatment after at least 5 days of treatment (i.e. no diminution of the daily number of stools at BSS 6-7 compared to first day of treatment; or worsening of CDI severity parameters)",{"count":145,"type":21},100,[57],"The clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) after standard of care treatment (either vancomycin or fidaxomicin) vs the pragmatic use of standard of care treatment (either vancomycin or fidaxomicin) in severe and non-severe first episode and first recurrence of Clostridioides difficile infection (CDI).\n\nExperimental arm: antibiotic treatment (vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days) followed by FMT by oral capsules (one FMT, i.e. 20 FMT capsules given on 2 consecutive days, and followed by a 2nd FMT in severe CDI).\n\nControl Arm: vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days.",[27],[63,64,150,65,151],"Fecal Microbiota Transplantation","Fidaxomicin","2026-05-29",{"date":98,"type":37},{"date":155,"type":37},"2023-03-15",{"date":157,"type":21},"2028-01-31",{"name":159,"class":78},"Benoit Guery",8,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":169,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"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":171,"type":21},852,[57],"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).",[175,176,177,27,60,69,178,179,180,181],"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":98,"type":37},{"date":185,"type":37},"2024-05-20",{"date":187,"type":21},"2027-10",{"name":189,"class":44},"Vedanta Biosciences, Inc.",215,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"100539605","phase-1-evaluation-of-exl01-a-new-live-biotherapeutic-product-to-prevent-recurrence-of-clostridioides-difficile-infection-in-high-risk-patients-100539605","NCT06306014","Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients","LIVEDIFF","Inclusion Criteria:\n\n* Adult patient ≥18 years of age\n* ≥3rd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in stool by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6 months with an interval ≤ 12 weeks since the end of treatment of the previous episode of resolved CDI or 2nd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in the stools by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6 months with an interval ≤ 12 weeks since the end of treatment of the previous episode of resolved CDI with at least one of the following risk factors:\n\n  * Age ≥70 years\n  * Chronic renal failure (haemodialysis or GFR\\\u003C60ml\u002Fmin\n  * History of severe or severe-complicated CDI (excluding current episode) according to ESCMID 2021 criteria\n  * ≥3 CDI in the last 12 months (including current episode)\n  * CDI associated with care defined as CDI occurring during hospitalisation (\\\u003C3 months)\n* On current or planned vancomycin treatment per os\n* Patient able to give free, informed and written consent\n* Enrolled in compulsory national social security scheme\n\nExclusion Criteria:\n\n* Currently participating or has participated in a study with an investigational compound or device within 3 months prior to the first dose of the study intervention.\n* Severe C. difficile infection severe (defined by the presence of a white blood cell count \\>15×10⁹ cells\u002FL or a body temperature \\>38.5°C or \\>50% increase in the patient's baseline creatinine related to CDI at the time of V1) and\u002For complicated (defined by any of the factors attributed to current Clostridioides difficile infection (CDI): hypotension, septic shock, elevated serum lactate, ileus, toxic megacolon, intestinal perforation or any fulminant course of the disease)\n* Refractory C. difficile infection defined as lack of response to well-conducted per os vancomycin or fidaxomicin treatment with ≥3 liquid stools per day after ≥5 days of treatment\n* Cirrhosis with Child C score\n* Hospitalization in continuing care unit or intensive care unit\n* Immunosuppression including :\n\n  * Malignant hemopathy under treatment (excluding CLL)\n  * HIV AIDS stage\n  * Stem cell allograft ≤ 12 months\n  * Aplasia (\\\u003C500 PNN\u002Fmm3) at inclusion\n  * Treatment with \\>20mg prednisone equivalent within 14 days prior to inclusion (excluding inhaled or topical treatment).\n* Personal history of gastrointestinal resection other than appendectomy (gastrectomy, esophagectomy, colonic or small bowel resection, short small bowel syndrome).\n* Personal history of small intestinal microbial overgrowth\n* Inflammatory bowel disease\n* Proven celiac disease\n* Current stoma (ileostomy or colostomy) or within the last 6 months, or any other intra-abdominal surgery within the 3 months prior to treatment\n* major surgery or trauma ≤ 4 weeks before the start of treatment\n* Antibiotic therapy in progress or planned during the study for an infection other than CDI\n* Surgery scheduled during the study requiring perioperative antibiotics.\n* -Women without contraception\\*, pregnant or breastfeeding women\n* History of hypersensitivity to EXL01 and\u002For to any of its excipients (D-mannitol, sucrose, maltodextrin, L-cysteine, L-cysteine hydrochloride, magnesium stearate and hydroxypropylmethylcellulose), and\u002For to soy or soy-containing products.\n* History of hypersensitivity to vancomycin as mentioned in local prescribing information.\n* Personal history of fecal microbiota transplantation \\\u003C 12 months\n* Persons deprived of liberty by judicial or administrative decision\n* Adults under legal protection or unable to give consent\n* Swallowing disorders making oral treatment impossible\n* Participation in another interventional study within 3 months prior to inclusion. (Patients who have entered the follow-up phase of an interventional study may participate provided that more than 3 months have elapsed since the last intervention).\n* Expected life expectancy of less than 6 months\n* Presents a known psychiatric disorder that would interfere with adequate cooperation with study requirements.\n* Regular use of illicit or recreational drugs\n* Anticipated administration during the study of treatment that is expected to cause diarrhea (chemotherapy, colonic preparation prior to colonoscopy)\n* History of chronic diarrhea (\\> 3 watery stools per day for \\> 4 weeks) not related to gastrointestinal infection.\n* Clinically significant medical or surgical condition not mentioned in the above criteria which, in the opinion of the investigator, could interfere with the administration of study drug, the interpretation of study safety or efficacy data, or compromise the safety or well-being of the subject.",{"count":199,"type":21},56,[118,24],"Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in Europe, with over 120,000 cases and almost 3,700 deaths per year. This infection is characterized by a high risk of recurrence after cure, ranging from almost 20% after a first episode to over 60% after 2 recurrences, or in the case of specific risk factors.\n\nCurrently, first-line treatment of CDI is based on oral antibiotics such as fidaxomicin or vancomycin. These antibiotic treatments, which are effective in 89% and 86% of first-episode cases respectively, do not correct the microbiological imbalance underlying the onset of CDI and may, on the contrary, encourage recurrence by contributing to the maintenance of a deleterious change in the microbiota (dysbiosis) through the elimination of bacteria other than C. difficile, due to their spectrum of activity. In a number of patients, this ecological imbalance can no longer be restored after antibiotic treatment, leading to multiple recurrences of CDI.\n\nIn this context, fecal microbiota transplantation (FMT) has been validated for over 10 years for the prevention of recurrence in multi-recurrent CDI. The principle of FMT is based on the use of a pharmaceutical preparation made from the stool of a healthy donor, administered within the digestive tract of a patient for therapeutic purposes.\n\nCurrently, in the case of multiple recurrences, it is the recommended first-line treatment (from 2 recurrences) and the most effective, with a clinical efficacy preventing recurrence of CDI in 69% to 89% of cases at 8 weeks post-treatment, with a good safety profile.\n\nAmong the microbial factors promoting CDI, the loss of the bacterial species Faecalibacterium prausnitzii constitutes a specific therapeutic target. F. prausnitzii is a commensal bacterium of the human gut, making up nearly 5% of the fecal microbiota, and has been shown to be associated with an individual's state of health. A drop in its relative abundance is associated with an increased risk of numerous diseases, such as Crohn's disease and colorectal cancer. In CDI, F prausnitzii is greatly diminished. Moreover, low abundance of F. prausnitzii is predictive of C. difficile recurrence. Its abundance in stools is increased after FMT and is also predictive of response to treatment. From a pathophysiological point of view, one of the preventive effects of F. prausnitzii on recurrence would be mediated by its ability to hydrolyze the bile acids involved in the germination of C. difficile spores.\n\nThe aim of this Phase I\u002FII trial is to assess the efficacy and safety of oral administration of EXL01, a single isolated unmodified strain of F. prausnitzii, in preventing CDI recurrence in high-risk patients at W8. The study will be conducted in 2 parts. The phase I (Part A) is planned to include 6 patients. The phase II (Part B) will include 50 patients in two arms (25 patients respectively in the placebo and EXL01 arm).",[27,203],"Recurrent Infection",[205,206,207,203],"Clostridioides difficile Infection","Live Biotherapeutic Product","Microbiota","2026-05-13",{"date":210,"type":37},"2026-05-15",{"date":212,"type":37},"2024-05-07",{"date":214,"type":21},"2027-01-07",{"name":216,"class":78},"Hospices Civils de Lyon",9,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":79},"100636722","long-term-outcomes-after-cdi-fmt-versus-antibiotic-only-treatment-100636722","NCT07569380","Long-Term Outcomes After CDI: FMT Versus Antibiotic-Only Treatment","Long-Term Outcomes After Clostridioides Difficile Infection (CDI): Comparative Follow-Up of FMT Versus Antibiotic-Only Treatments (LTO-CDI Cohort)","LTO-CDI","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Symptomatic, microbiologically verified index CDI from February 1 2016 to December 31 2024\n* Having received CDI treatment at Umeå University Hospital (antibiotic-only or FMT)\n\nExclusion Criteria:\n\n* Age below 18 years at follow-up\n* Index CDI diagnosis not meeting ESCMID case definition\n* Testing positive for another gastrointestinal pathogen (virus\u002Fbacteria) that is more plausible to explain the clinical picture at index CDI episode\n* Declines participation",{"count":227,"type":21},250,"OBSERVATIONAL","The goal of this observational study is to learn about the long-term effects of fecal microbiota transplantation (FMT) compared with antibiotic-only treatment in adults who were treated for Clostridioides difficile infection (CDI) at Umeå University Hospital between 2016 and 2024. The main questions it aims to answer are:\n\n* Do patients treated with FMT maintain higher gut bacterial diversity up to 10 years after CDI compared with patients treated with antibiotics only?\n* Do donor gut bacteria introduced by FMT persist long-term in the recipient's gut?\n* Are there differences in gut metabolism, gut barrier function, and systemic inflammation between FMT-treated and antibiotic-only treated patients at long-term follow-up?\n* What are the long-term safety outcomes - including new diseases, hospitalizations, and mortality - in FMT-treated versus antibiotic-only treated patients?\n\nResearchers will compare patients who received FMT to patients who received antibiotics only to see if FMT leads to lasting differences in gut microbiota, metabolism, immune markers, and clinical outcomes.\n\nParticipants will:\n\n* Attend a single study visit at Umeå University Hospital\n* Provide samples of blood, stool, urine, and a nasal swab\n* Complete two quality-of-life questionnaires\n\nClinical data will be collected from medical records for all participants.",[27],[232,124,233,234,235,236,237],"Clostridioides difficile infection","Gut microbiota","Microbiome engraftment","Intestinal barrier","Antibiotic treatment","Observational study","NOT_YET_RECRUITING","2026-04-28",{"date":241,"type":37},"2026-05-06",{"date":243,"type":21},"2026-05-01",{"date":245,"type":21},"2031-05-01",{"name":247,"class":78},"Umeå University",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":266,"leadSponsor":268,"locationsCount":79},"100584085","early-phase-1-prevention-of-recurrence-of-clostridioides-difficile-colitis-with-ursodeoxycholic-acid-ucda-as-a-supplement-to-standard-therapy-100584085","NCT06884748","Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy","PREVENTION OF RECURRENCE OF CLOSTRIDIOIDES DIFFICILE COLITIS WITH URSODEOXYCHOLIC ACID (UCDA) AS A SUPPLEMENT TO STANDARD THERAPY","PREVENT","Inclusion Criteria:\n\n* Eligible patients: C. diff. toxin +ve patients \\> 18 years with one or more risk factors for recurrence \\[6,7\\] requiring standard treatment with Flagyl, Vancomycin or fidaxomicin.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C 6 months; fulminant colitis; ileus; decompensated liver disease; pregnancy and lactating females; Inability to give informed consent.",{"count":257,"type":21},30,[259],"EARLY_PHASE1","The goal of this clinical trial is to determine whether Ursodeoxycholic Acid (UDCA) can help prevent recurrence of Clostridioides difficile (C. diff) colitis when used along with standard antibiotic treatment. C. diff colitis is a serious infection that can return after treatment, and researchers want to see if UDCA can reduce this risk.\n\nThis study aims to answer three main questions. First, can UDCA help prevent C. diff from returning after standard treatment? Second, does adding UDCA to treatment lower the need for repeated antibiotic use? Third, is UDCA safe and well-tolerated for people with C. diff?\n\nParticipants in the study will be adults diagnosed with C. diff colitis who have risk factors for recurrence. Each participant will receive standard antibiotic treatment, which may include Vancomycin, Fidaxomicin, or Metronidazole. In addition to their antibiotic therapy, participants will take UDCA at a dose of 500 mg three times a day for up to eight weeks. If a participant's stool test shows they are C. diff negative at four weeks, they will stop taking UDCA early.\n\nResearchers will monitor participants throughout the study. Stool samples will be tested at the beginning, after four weeks, and at the end of the study. If a participant develops diarrhea, a stool test will check for C. diff. If C. diff is negative, the UDCA dose will be reduced. Weekly phone calls will be made to check for side effects and ensure participants are following the treatment plan.\n\nC. diff colitis is a common and serious infection, with up to 46 percent of high-risk patients experiencing recurrence. Current treatments rely on antibiotics, which can disrupt gut bacteria and increase the risk of reinfection. UDCA is a naturally occurring bile acid that may help prevent C. diff from growing, reducing the need for repeated antibiotic treatment. If successful, this study could introduce a new way to prevent C. diff from coming back, helping patients recover more effectively while reducing antibiotic use.\n\nEligible participants must be at least 18 years old, have a positive C. diff test, and be receiving standard antibiotic treatment for C. diff. People who have severe or life-threatening C. diff colitis, a life expectancy of less than six months, serious liver disease, or are pregnant or breastfeeding will not be eligible to participate.\n\nUDCA is FDA-approved and has been used safely for decades in liver diseases and gallstone treatment. Some people may experience mild side effects, such as diarrhea, nausea, or stomach discomfort. Participants will be closely monitored for safety throughout the study.\n\nThis trial will take place within the Froedtert and Medical College of Wisconsin healthcare system in Milwaukee, Wisconsin.",[27],[232],{"date":264,"type":37},"2026-04-29",{"date":243,"type":21},{"date":267,"type":21},"2028-05-01",{"name":269,"class":78},"Medical College of Wisconsin",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":79},"100504765","phase-1-xylitol-use-for-decolonization-of-c-difficile-in-patients-with-ibd-100504765","NCT05852587","Xylitol Use for Decolonization of C. Difficile in Patients With IBD","Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Male or female ≥ 18 years of age\n3. IBD diagnosis (CD, UC or indeterminant Colitis will be permitted)\n4. Inactive or mild IBD (HBI score ≤ 7; Partial Mayo score ≤ 4)\n5. Presenting for outpatient colonoscopy or clinic appointment for any indication\n\nExclusion Criteria:\n\n1. Unable to provide consent\n2. Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy)\n3. Unable to complete study procedures\n4. Chronic use of antibiotics\n5. Inability or unwillingness to swallow capsules\n6. Allergy to xylitol\n7. Stool positive for Listeria monocytogenes",{"count":278,"type":21},99,[118],"This is a randomized, placebo-controlled, dose-ranging study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in IBD patients. A total of 99 patients who meet eligibility criteria will be randomized 1:1:1 to one of two xylitol doses or placebo arm. All arms will receive an identical capsule dosing for four weeks. Microbiome assessment and C. difficile testing will be performed at baseline, week 4, 8, 26, and 52.",[122,27],[283,284],"Crohn's Disease","Ulcerative colitis","2026-02-24",{"date":287,"type":37},"2026-02-25",{"date":289,"type":21},"2026-08-01",{"date":291,"type":21},"2033-01-01",{"name":293,"class":78},"Brigham and Women's Hospital",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":315},"100464629","phase-2-lmn-201-for-prevention-of-c-difficile-infection-recurrence-100464629","NCT05330182","LMN-201 for Prevention of C. Difficile Infection Recurrence","A Phase 2, Randomized, Double-blind, Placebo-controlled Study of LMN-201 for Prevention of C. Difficile Infection Recurrence","Inclusion Criteria:\n\n1. Male or female, aged 18 or older.\n2. Diagnosis of CDI defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency (Bristol Stool Scale 5, 6, or 7); a positive stool C. difficile toxin B immunoassay (stool collected no more than 7 days before first dose of LMN-201\u002Fplacebo), and no other likely explanation for diarrhea. NOTE: Diarrhea is not required to be present on the day of enrollment.\n3. Provision of signed and dated informed consent form.\n4. Scheduled to receive or planning to receive a ≤28-day course of SOC antibiotic therapy for CDI. Participant must have been diagnosed with CDI for 7 or fewer days at time of initial study drug administration. SOC antibiotic therapy is defined as the receipt of oral fidaxomicin or oral metronidazole or oral vancomycin (see Section 8.2.6)\n5. May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.\n6. Ability to take oral medication and willingness to adhere to the study medication regimen.\n7. Stated willingness and ability to comply with all study procedures and availability for the duration of the study and investigator believes individual will complete the study.\n8. Access to a mobile smartphone.\n9. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration.\n10. For males of reproductive potential: agreement to use condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of study drug administration.\n\nExclusion Criteria:\n\n1. Fulminant C. difficile colitis.\n2. Admitted or expect to be admitted to an intensive care unit.\n3. Underlying gastrointestinal disorder characterized by diarrhea including but not limited to chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, enteric parasitic infection, viral enteritis, bacterial enteritis (salmonella, shigella, ETEC, etc.).\n4. Neutropenia (absolute neutrophil count of \\\u003C 1000 per microliter for any reason).\n5. Current or previous treatment in past 3 months with any therapy likely to influence the outcome of this study, including but not limited to the following:\n\n   1. Bezlotoxumab (Zinplava, Merck \\& Co.), or another antibody against C. difficile toxin(s)\n   2. C. difficile vaccine\n   3. SER-109 (Seres Therapeutics)\n   4. CP101 (Finch Therapeutics)\n   5. VE303 (Vedanta Therapeutics)\n   6. Fecal microbiota transplant\n   7. Current therapy with oral exchange resins\n   8. Protracted exposure to mu-agonist opioids and\u002For anticholinergic medication prescribed for diarrheal symptoms (unable to stop mu-agonist opioid treatment unless on a stable dose as of onset of diarrhea and no increase in dose planned for the duration of the study.)\n6. Treatment with SOC antibiotic therapy is planned for longer than a 28-day period.\n7. Pregnancy, anticipated pregnancy, or breastfeeding.\n8. Inability or unwillingness to swallow numerous, relatively large capsules containing study drug or placebo because of a swallowing disorder or dysphagia.\n9. Inability to pass swallowed capsules into the distal small intestine because of gastroparesis, repetitive vomiting, or anatomic narrowing in the esophagus, stomach, or small intestine.\n10. Psychiatric illness that would affect compliance with medications, study capsules, or follow-up.\n11. Status as an inmate, residential mental health program, or residential substance abuse program.\n12. Terminal illness with limited life expectancy of less than 24 weeks.\n13. Poor concurrent medical risks with clinically significant co-morbid disease such that, in the opinion of the investigator, the patient should not be enrolled.\n14. Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the individual, would make it unlikely for the individual to complete the study, or would confound the results of the study.\n\n    * Note: Use of probiotics and other food supplements (e.g., yogurt, kefir, kimchi, etc.) are not exclusionary.\n    * Note: Assuming participants meet all of the inclusion criteria and none of the exclusion criteria, participants with underlying malignancy with a good life expectancy in the study are not excluded.",{"count":302,"type":21},375,[24,57],"This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.",[27],"2026-02-09",{"date":308,"type":37},"2026-02-10",{"date":310,"type":37},"2024-08-29",{"date":312,"type":21},"2027-12-01",{"name":314,"class":44},"Lumen Bioscience, Inc.",16,{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":324,"targetDuration":326,"studyType":228,"phases":4,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":79},"100621705","clostridioides-difficile-understanding-responses-and-treatment-effects-100621705","NCT07374094","Clostridioides Difficile: Understanding Responses and Treatment Effects","Studies of Treatment Effects, Host-Pathogen Responses, and Therapeutic Mechanisms in Clostridioides Difficile Infection","CURE-CDI","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Symptomatic, microbiologically verified Clostridioides difficile infection\n* Receiving inpatient or outpatient care at Umeå University Hospital\n* Able and willing to provide written informed consent\n* Willing to participate in protocol-driven follow-up for up to 5 years\n\nExclusion Criteria:\n\n* Age below 18 years\n* Inability to provide written informed consent",{"count":325,"type":21},200,"5 Years","The goal of this observational study is to learn how different treatments for Clostridioides difficile infection (CDI) work, and which biological mechanisms are involved in recovery. The study will compare standard antibiotic treatment and fecal microbiota transplantation (FMT).\n\nThe main questions it aims to answer are:\n\n* How do antibiotic treatment and FMT affect treatment outcome in CDI?\n* How does the gut microbiota change during and after treatment?\n* Which microbial and metabolic factors are associated with recovery or treatment failure?\n* How does treatment affect the intestinal barrier, immune response, and patient-reported quality of life?\n\nParticipants with CDI will receive treatment as part of routine clinical care, either antibiotics or FMT. Researchers will follow participants over time and collect biological samples to study treatment effects.\n\nParticipants will:\n\n* Provide stool samples during the acute infection and during follow-up\n* Have treatment outcomes assessed at 2 and 8 weeks\n* Be followed for up to 5 years to study long-term effects\n* Provide blood and urine samples during follow-up\n* Provide nasal samples to study potential microbiota changes at distant body sites\n* Complete questionnaires on symptoms and health-related quality of life\n* In a subgroup, undergo repeated sigmoid biopsies to study intestinal mucosal healing\n\nThe results are expected to increase understanding of how FMT and antibiotics lead to recovery in CDI and may support improved and more targeted future treatments.",[27],[232,330,124,233,234,331,332,235,333,236,237],"Recurrent Clostridioides difficile infection","Dysbiosis","Microbial metabolites","Immune response","2026-01-20",{"date":336,"type":37},"2026-01-28",{"date":338,"type":21},"2026-01-26",{"date":340,"type":21},"2045-12",{"name":247,"class":78},{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":79},"100577495","early-phase-1-pilot-trial-of-xylitol-for-c-difficile-de-colonization-in-patients-with-inflammatory-bowel-disease-100577495","NCT06799039","Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Male or female ≥ 18 years of age\n3. IBD diagnosis (CD, UC or indeterminant Colitis will be permitted)\n4. Inactive or mild IBD (HBI score ≤ 4; Partial Mayo score ≤ 4)\n5. Presenting for outpatient colonoscopy or clinic appointment\n\nExclusion Criteria:\n\n1. Unable to provide consent.\n2. Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy)\n3. Unable to complete study procedures.\n4. Chronic use of antibiotics.\n5. Inability or unwillingness to swallow capsules.\n6. Allergy to xylitol.\n7. Currently pregnant or breastfeeding",{"count":349,"type":21},69,[259],"This 3+3 dose escalation pilot trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the Inflammatory Bowel Disease (IBD) patient population.",[353,27],"Inflammatory Bowel Disease (IBD)",[355,356,357],"C. Difficile","Decolonization","IBD","2025-12-08",{"date":360,"type":37},"2025-12-16",{"date":362,"type":21},"2026-09-01",{"date":364,"type":21},"2031-09-01",{"name":293,"class":78},{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":376,"conditions":377,"keywords":378,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":79},"100577180","phase-4-use-of-fidaxomicin-compared-to-vancomycin-for-decolonization-of-c-difficile-in-patients-with-inflammatory-bowel-disease-100577180","NCT06794944","Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Male or female \\> 18 years of age.\n3. IBD diagnosis (CD, UC or indeterminant Colitis will be permitted.)\n4. Presenting for outpatient colonoscopy for any indication.\n\nExclusion Criteria:\n\n1. Unable to provide consent.\n2. Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy.)\n3. Unable to complete study procedures.\n4. Chronic use of antibiotics.\n5. Inability or unwillingness to swallow capsules.\n6. Allergy or sensitivity to vancomycin, fidaxomicin, or microcrystalline cellulose.",{"count":373,"type":21},60,[375],"PHASE4","This is a randomized, double-blind study to assess the safety and efficacy of fidaxomicin compared to vancomycin for decolonization of C. difficile in IBD patients. A total of 60 patients who meet eligibility criteria will be randomized 1:1 to either the fidaxomicin or vancomycin arm. The vancomycin arm will receive a dose of 125 mg PO q 6 hours for 10 days. The fidaxomicin arm will receive 200 mg PO BID for 10 days. In order to ensure blinding, both antibiotics will be concealed in opaque 00 capsule shells. In addition, those in the fidaxomicin arm will receive 2 placebo capsules so that all participants will receive 4 capsules daily for 10 days. Microbiome assessment and C. difficile testing will be performed at baseline, day 5, day 10, and weeks 4, 8, and 26.",[353,27],[67,379,121],"Crohn's Disease","2025-10-31",{"date":382,"type":37},"2025-11-03",{"date":384,"type":21},"2026-09",{"date":386,"type":21},"2031-09",{"name":293,"class":78},{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":399,"conditions":400,"keywords":403,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"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":397,"type":21},424,[90],"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.",[27,60,401,402,151,65],"Fecal Microbiota Transplantation (FMT)","Comparative Effectiveness of CDI Treatments",[63,69,124,151,65,404],"Recurrent infection","2025-08-06",{"date":407,"type":37},"2025-08-13",{"date":409,"type":21},"2025-10",{"date":411,"type":21},"2027-04-30",{"name":413,"class":78},"Medical University of Warsaw",{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":11,"sex":17,"minAge":422,"maxAge":423,"enrollmentInfo":424,"targetDuration":4,"studyType":22,"phases":426,"briefSummary":427,"conditions":428,"keywords":433,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":4},"100588980","phase-2-a-flexible-clinical-trial-to-test-if-freeze-dried-fecal-microbiota-therapy-helps-treat-diarrhea-predominant-irritable-bowel-syndrome-or-prevent-recurring-c-difficile-infections-100588980","NCT06948461","A Flexible Clinical Trial to Test if Freeze-dried Fecal Microbiota Therapy Helps Treat Diarrhea-predominant Irritable Bowel Syndrome or Prevent Recurring C. Difficile Infections.","An Adaptive Basket Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Therapy in Management of Irritable Bowel Syndrome-diarrhea Predominant or Prevention of Recurrent Clostridioides Difficile Infection","ORAL-LYO-FMT","Inclusion Criteria:\n\n* 19 years of age and older\n* Able to provide informed consent\n* Must have at least one of the 3 following conditions:\n\n  1. Irritable bowel syndrome with diarrhea- predominant (IBS-D) as reported by patients of type 6 or 7 in Bristol stool chart and Rome IV diagnostic criteria:\n\n     1. Recurrent abdominal pain\u002Fdiscomfort\\*\\* at least 3 days\u002Fmonth in last 3 months associated with ≥2 of the following:\n     2. Symptom improvement with defecation;\n     3. Onset associated with change in stool frequency;\n     4. Onset associated with change in stool formation (with this last criterion fulfilled for last 3 months with symptom onset \\> 6 months prior to diagnosis\n  2. Primary or 1 episode recurrent Clostridioides difficile infection which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.\n  3. 2 or more episodes of recurrent Clostridioides difficile infection, which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.\n\nExclusion Criteria:\n\n1. Planned or actively taking other investigational product\n2. Unable to tolerate FMT or take oral medications.\n3. Requiring systemic antibiotic therapy at the time of FMT\n4. Actively taking probiotics \\[Consumption of yogurt is permitted\\]\n5. Severe allergy to any food and\u002For medications\n6. Major open abdominal surgery within the past 60 days\n7. Receipt of chemotherapy or radiation within 8 weeks of screening.\n8. Active small bowel obstruction.\n9. Those who are pregnant or plan to be pregnant within 3 months of the study. This will be determined on history alone at time of study entry and subsequent follow up.\n10. Those who are breastfeeding or plan to breast feed during the trial\n11. Not expected to survive beyond 30 days.\n12. Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the study team\n\nExclusion Criteria:\n\n\\-","19 Years","120 Years",{"count":425,"type":21},63,[24],"The goal of this clinical trial is to learn if oral lyophilized fecal microbiota therapy (ORAL-LYO-FMT) helps treat diarrhea-predominant irritable bowel syndrome (IBS-D) and prevent the recurrence of Clostridioides difficile infection (rCDI). The main questions it aims to answer are:\n\n* Does ORAL-LYO-FMT reduce IBS symptoms?\n* Does it prevent rCDI after treatment?\n* What side effects or safety concerns might occur? Researchers will compare ORAL-LYO-FMT to a placebo (a look-alike capsule with no active treatment) to see how well it works.\n\nParticipants will:\n\n* Be randomly assigned to take ORAL-LYO-FMT or placebo for up to 7 weeks\n* Take capsules three times per week (Monday, Wednesday, Friday)\n* Complete health questionnaires and have follow-up visits by phone or in person for up to 6 months The trial also looks at changes in quality of life, mood, and new or ongoing medical conditions over time.",[429,430,431,432,27],"Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D)","Recurrent Clostridioides Difficile Infection (rCDI)","Fecal Microbiota Therapy (FMT)","Irritable Bowel Syndrome (IBS)",[434,435,436,437,125,438,69,439],"IBS","Irritable bowel syndrome","rCDI","Fecal Microbiota Therapy","Gut Health","Clostridioides difficile infection, Recurrent","2025-04-21",{"date":442,"type":37},"2025-04-29",{"date":444,"type":21},"2025-09-01",{"date":446,"type":21},"2026-12",{"name":448,"class":449},"PharmaPlanter Technologies Inc","NETWORK",{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":423,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":79},"100459047","fmt-in-initial-cdi-100459047","NCT05257538","FMT in Initial CDI","Fecal Microbiota Transplantation in Initial Clostridioides Difficile Enteritis: a Randomized, Placebo-controlled Trial","FinCDI","Inclusion Criteria:\n\n* \\>18 years\n* C. difficile PCR in feces positive and clinical symptoms of enteritis.\n* Full resolution of diarrhea during antibiotic treatment for C. difficile\n* No other ongoing antibacterial treatments.\n* No ongoing probiotics.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Pregnant\n* Ongoing need for antibacterial treatment\n* Life expectancy \\\u003C 1 year\n* Prior C. difficile infection in preceding 3 months\n* Unable to provide written consent, due to dementia for example.\n* Fecal incontinence i.e. inability to retain enema.",{"count":459,"type":21},140,[90],"The study explores fecal microbiota transfer via retention enema after the first clostridioides difficile episode.",[27],"2025-04-08",{"date":465,"type":37},"2025-04-11",{"date":467,"type":37},"2021-08-01",{"date":469,"type":21},"2028-02-28",{"name":471,"class":472},"Turku University Hospital","OTHER_GOV",{"id":474,"slug":475,"hasResults":11,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":79},"100582140","prevention-of-clostridium-difficile-infections-using-lactobacillus-plantarum-299v-strain-in-nephrology-and-transplantation-department-100582140","NCT06859437","Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department","Inclusion Criteria:\n\n* over 18 years old\n* organ transplantation or receiving immunosuppressive drugs for any other reasons\n* antibiotics therapy\n\nExclusion Criteria:\n\n* no consent to participate in the study",{"count":55,"type":21},[90],"The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized in the nephrology and transplantation ward.\n\nAdutt patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study.\n\nPatients who meet the above criteria for inclusion in the study will be assigned to one of two groups. Patients in group I (study) will receive a probiotic containing the Lactobacillus plantarum 299v strain of bacteria as part of the prophylaxis of Clostridioides difficile infection. The daily dose is 1 capsule containing approximately 10x109 colony-forming units of live bacteria taken orally with a meal. Patients in group II (control) will receive a placebo. The duration of probiotic or placebo use will be 3 months. Assignment to groups I and II will be random. The number of patients in each group will be 150.\n\nParticipants will be divided into two groups. First group will receive one capsule of Lactobacillus plantarum 299v (LP299v) orally per a day. Second group will receive placebo. The observation period will last 3 months. The evaluation will consist of an interview, physical examination and laboratory tests.",[27],"2025-02-27",{"date":485,"type":37},"2025-03-05",{"date":487,"type":37},"2024-10-01",{"date":489,"type":21},"2027-10-31",{"name":491,"class":78},"Medical University of Silesia",{"id":493,"slug":494,"hasResults":11,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":502,"briefSummary":503,"conditions":504,"keywords":505,"overallStatus":238,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":513,"leadSponsor":515,"locationsCount":79},"100580371","early-phase-1-cmts0929-for-clostridioides-difficile-infection-100580371","NCT06836427","CMTS0929 for Clostridioides Difficile Infection","CMTS0929 for Clostridioides Difficile Infection: a Prospective, Open-label, Single-arm Clinical Study","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to enter the study:\n\n1. At the time of informed consent, the age is between 18 and 75 years old (inclusive), including both males and non - pregnant, non - lactating females.\n2. At the time of screening, meet the diagnostic criteria for Clostridioides difficile infection: a)There is a medical record proving a confirmed CDI before screening (laboratory tests show positive results for Clostridioides difficile or its toxins): positive results in Clostridioides difficile toxin detection (determined by EIAs) or colonoscopy indicating pseudomembranous colitis; or positive GDH with negative toxin results, along with obvious predisposing factors and diarrhea. b)Have an episode of CDI - related diarrhea, that is, having at least 3 bowel movements per day for at least two consecutive days and the stools are unformed (Bristol Stool Form Scale score of 6 - 7).\n3. The subject or their legal representative provides informed consent, fully understands the purpose of the study, can communicate well with the researcher, and can understand and comply with all the requirements of this study.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria must be excluded from the study:\n\n1. Subjects with immunodeficiency (such as HIV infection, or absolute neutrophil count \\\u003C 0.5×10⁹\u002FL, or total lymphocyte count \\\u003C 0.5×10⁹\u002FL, etc.), or those using immunosuppressants, or those using medium - to high - dose steroid hormones (≥20 g\u002Fd prednisone or equivalent steroid hormones).\n2. Subjects with rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis that, as evaluated by the researcher, cannot undergo cTET.\n3. Before screening, subjects are diagnosed or clinically suspected of having an infection with other pathogenic microorganisms in addition to Clostridioides difficile.\n4. Within 6 months before screening, subjects have undergone major abdominal surgery (excluding laparoscopic cholecystectomy or appendectomy), or have previously undergone partial or total colectomy, or partial small intestine resection, or gastroduodenal surgery.\n5. At the time of screening, the subject or legal representative refuses to use effective contraceptive measures within 3 months after the last treatment.\n6. As judged by the researcher, the subject is not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subject.","75 Years",{"count":501,"type":21},12,[259],"This is a prospective, open-label, single-arm study to explore the safety and the efficacy of CMTS0929 for patients with Clostridioides difficile infection (CDI).",[27],[506,232,507,508],"CMTS0929","efficacy","safety","2025-02-19",{"date":511,"type":37},"2025-02-20",{"date":511,"type":21},{"date":514,"type":21},"2030-07-01",{"name":516,"class":78},"The Second Hospital of Nanjing Medical University",{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":11,"sex":17,"minAge":524,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":79},"100576705","study-of-clostridioides-difficile-in-infants-100576705","NCT06788769","Study of Clostridioides Difficile in Infants","Retrospective Analysis of Risk Factors and Microbiome Alterations in Infant Clostridioides Difficile Infection","Inclusion Criteria:\n\n1. Age Range: Infants aged 0 to 2 years (inclusive) at the time of sample collection or medical record documentation.\n2. Data Availability: Complete medical records or available stool samples within the study's retrospective time frame.\n3. Group-Specific Criteria:\n\n   CDI Patients: Documented diarrhea or related gastrointestinal symptoms, with laboratory-confirmed C. difficile by PCR or culture.\n\n   Asymptomatic Carriers: Positive C. difficile test (PCR or culture) in the absence of diarrhea or other clinical CDI symptoms.\n\n   Healthy Controls: Negative C. difficile test and no gastrointestinal symptoms indicative of CDI.\n4. Consent\u002FAuthorization:Retrospective data (e.g., existing medical records or stored biosamples) may be included under a waiver of consent if approved by the institutional review board (IRB). However, any new information obtained directly from participants or their guardians (e.g., via questionnaires) requires explicit informed consent.\n\nExclusion Criteria:\n\n1. Incomplete Data: Infants whose medical records lack sufficient information to confirm their CDI status or those without adequate stool sample results.\n2. Ambiguous Diagnosis: Patients presenting with other infectious diseases or conditions that could not rule out alternative diagnoses for diarrhea (e.g., confirmed concurrent viral or parasitic infections) without conclusive C. difficile testing.\n3. Severe Comorbidities: Infants with life-threatening congenital conditions (e.g., severe immunodeficiency syndromes) if these conditions significantly alter the gut microbiota or confound CDI diagnosis.","1 Day","2 Years",{"count":55,"type":21},"Clostridioides difficile infection (CDI) poses an increasing threat to infant and young child health, with detection rates rising annually. This retrospective study aims to explore the epidemiological characteristics, clinical manifestations, and potential biomarkers of CDI in children aged 0-2 years by examining three cohorts: (1) infants diagnosed with CDI, (2) asymptomatic carriers of C. difficile, and (3) healthy controls. Fecal samples from each group will undergo metagenomic sequencing and metabolomic profiling, coupled with questionnaire-based surveys for risk factor assessment. The findings are anticipated to identify key high-risk factors, elucidate the pathogenic mechanisms underlying infant CDI, and support the development of early diagnostic tools and preventive strategies.",[27],[530,531],"Clostridioides Difficile","Infants","2025-01-16",{"date":534,"type":37},"2025-01-23",{"date":536,"type":37},"2024-07-01",{"date":538,"type":21},"2026-12-30",{"name":540,"class":78},"Westlake University",{"id":542,"slug":543,"hasResults":11,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":549,"enrollmentInfo":550,"targetDuration":4,"studyType":22,"phases":552,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":135},"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":551,"type":21},260,[24],"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.",[27,555,556,557],"Clostridium Difficile Infection","Clostridium Difficile Diarrhea","Clostridia Difficile Colitis","2024-10-22",{"date":560,"type":37},"2024-10-26",{"date":562,"type":37},"2021-06-01",{"date":564,"type":21},"2027-06-30",{"name":566,"class":78},"University of Virginia",{"id":568,"slug":569,"hasResults":11,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":575,"conditions":576,"keywords":579,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":79},"100354490","rescue-fecal-microbiota-transplantation-for-national-refractory-intestinal-infections-100354490","NCT03895593","Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections","Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry","Inclusion Criteria: National patients with refractory intestinal infections receiving rescue FMT from the China Microbiota Transplantation System from September 2015 to December, 2029 will be included.\n\n\\-\n\nExclusion Criteria: Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT.\n\n\\-",{"count":145,"type":21},"A national data registry of patients receiving the rescue fecal microbiota transplantation for the refractory intestinal infections from the China Microbiota Transplantation System was designed to assess the short-term and long-term safety and efficacy.",[577,27,578],"Intestinal Infection","Antibiotic-associated Diarrhea",[580,581,582,578,583],"fecal microbiota transplantation","intestinal infection","clostridioides Difficile Infection","Washed microbiota transplantation","2024-02-27",{"date":586,"type":37},"2024-02-29",{"date":588,"type":37},"2015-09-25",{"date":590,"type":21},"2029-05-01",{"name":516,"class":78},{"id":593,"slug":594,"hasResults":11,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":11,"sex":17,"minAge":599,"maxAge":600,"enrollmentInfo":601,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":602,"conditions":603,"keywords":604,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":79},"100524282","washed-microbiota-transplantation-for-clostridioides-difficile-infection-100524282","NCT06106698","Washed Microbiota Transplantation for Clostridioides Difficile Infection","Washed Microbiota Transplantation for Clostridioides Difficile Infection: a Real World Research","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to enter the study:\n\n1. At the time of informed consent, male or non-pregnant or non-lactating female.\n2. The diagnostic criteria for C. difficile infection are met during screening:\n\n   1. Medical records confirming CDI prior to screening (laboratory tests are positive for Clostridium difficile or its toxin): Clostridium difficile toxin test is positive (determined by EIisa test), or colonoscopy indicates pseudomembranous enteritis; Or Glutamate dehydrogenase positive, toxin negative, there are obvious causes and diarrhea.\n   2. CDI-related diarrhea episodes, i.e., defecation ≥3 times\u002Fday for at least two consecutive days with unformed stools (Bristol score 6-7).\n3. The subject or his\u002Fher legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria must be excluded from the study:\n\n1. Subjects with immune deficiencies (such as HIV infection, or neutrophils \\\u003C0.5×109\u002FL in absolute value, or lymphocytes \\\u003C0.5×109\u002FL, etc.), or on immunosuppressants, or on medium to high doses of steroid hormones (≥20g\u002Fd of prednisone or equal doses of steroid hormones).\n2. There is rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis assessed by the investigator and colonic transendoscopic enteral tubing cannot be performed.\n3. Confirmed or clinically suspected infection with pathogenic microorganisms other than Clostridium difficile prior to screening.\n4. Have had major abdominal surgery (other than laparoscopic gallbladder or appendectomy), previous partial or total colectomy, previous partial small intestinal resection, or previous gastroduodenal surgery within 6 months prior to screening.\n5. At the time of screening, the subject or his\u002Fher legal representative refuses to take effective contraception within 3 months after the last treatment.\n6. According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.","3 Years","100 Years",{"count":145,"type":21},"This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation （WMT） for patients with Clostridioides Difficile Infection （CDI）.",[27],[605,27,606,578],"washed microbiota transplantation","Intestinal infection","2023-10-24",{"date":609,"type":37},"2023-10-30",{"date":611,"type":37},"2023-07-22",{"date":613,"type":21},"2029-12",{"name":516,"class":78}]