[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clostridium-difficile-infection-recurrence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clostridium-difficile-infection-recurrence":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,79,104],{"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":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100534332","phase-3-ve303-for-prevention-of-recurrent-clostridioides-difficile-infection-100534332",false,"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","ALL","12 Years",{"count":20,"type":21},852,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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).",[27,28,29,30,31,32,33,34,35,36],"Clostridium Difficile","Clostridium Difficile Infections","Clostridium Difficile Infection Recurrence","Clostridioides Difficile Infection","Clostridioides Difficile Infection Recurrence","CDI","C. Diff Infection","Recurrent Clostridium Difficile Infection","C.Difficile Diarrhea","Diarrhea Infectious","RECRUITING","2026-05-28",{"date":40,"type":41},"2026-06-02","ACTUAL",{"date":43,"type":41},"2024-05-20",{"date":45,"type":21},"2027-10",{"name":47,"class":48},"Vedanta Biosciences, Inc.","INDUSTRY",215,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100632407","phase-2-acx-362e-ibezapolstat-for-oral-treatment-of-recurrent-clostridioides-difficile-infection-100632407","NCT07513285","ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection","A Phase 2 Interventional, Open-Label, Single-Arm Trial of Oral Ibezapolstat (ACX-362E) for Treatment and Reduction of Recurrent Clostridioides Difficile Infection in Patients With Multiple Recurrent Infections (IBZ-PATHFINDER)","Inclusion Criteria:\n\n* Confirmed diagnosis of CDI as defined by 1) the presence of diarrhea, defined as passage of ≥ 3 UBMs within 24 hours before study Day 1, AND 2) a stool test result positive for the presence of C. difficile free toxins\n* Three or more CDI episodes in the past 12 months, including the current episode, with each episode defined as ≥ 3 unformed stools in 24 hours associated with positive C. difficile toxin test.\n* At least 1 of the protocol-qualifying prior CDI episodes, not including the current episode, has been treated with oral vancomycin or with fidaxomicin\n\nExclusion Criteria:\n\n* Severe, complicated, or life-threatening fulminant CDI with evidence of hypotension (systolic blood pressure \\\u003C 90 mmHg), septic shock, peritoneal signs or ileus, or toxic megacolon\n* Received more than 24 hours of dosing with antibiotics for the current CDI episode:\n* Received a live biotherapeutic product (LBP) (Rebyota® or Vowst™) within the past 12 weeks\n* Received or current use of anti-C. difficile antibodies, eg, IV immunoglobulin \\[IVIG\\], bezlotoxumab\n* Active inflammatory bowel disease (Crohn's disease, ulcerative colitis) with chronic diarrhea within 12 weeks before Baseline, or with a history of symptoms \\> 12 weeks before Baseline without evidence of mucosal healing on colonoscopy within the past year.\n* Active irritable bowel syndrome with chronic diarrhea in the past 12 weeks.\n* Active gastroenteritis because of Salmonella, Shigella, Escherichia coli 0157H7, Yersinia or Campylobacter, other bacteria, a parasite, or a virus within the past 2 weeks\n* Major GI surgery (eg, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).\n* Known current history of a severely compromised immune system","18 Years","90 Years",{"count":60,"type":21},20,[62],"PHASE2","Single-arm trial to evaluate the safety and efficacy of ACX-362E \\[ibezapolstat\\] in patients with recurrent C. difficile infection (CDI).",[29],[66,67,68],"Clostridioides difficile","Cdiff","Recurrent Clostridioides difficile","NOT_YET_RECRUITING","2026-04-02",{"date":72,"type":41},"2026-04-07",{"date":74,"type":21},"2026-08-19",{"date":76,"type":21},"2027-11-24",{"name":78,"class":48},"Acurx Pharmaceuticals Inc.",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100328940","outcomes-and-data-collection-for-fecal-microbiota-transplantation-for-the-treatment-of-recurrent-clostridium-difficile-100328940","NCT03562741","Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile","Inclusion Criteria:\n\n* Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy.\n* Failed standard therapy with oral metronidazole and\u002For oral vancomycin\n* One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity\n\nExclusion criteria:\n\n* Age \\\u003C16 years old\n* patients with acute severe colonic dilation at risk for colonic perforation","16 Years",{"count":87,"type":21},500,[89],"NA","The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.",[29,92],"Clostridium Difficile Infection","2026-02-18",{"date":95,"type":41},"2026-02-20",{"date":97,"type":41},"2014-01-16",{"date":99,"type":21},"2029-01-16",{"name":101,"class":102},"Krunal Patel","OTHER",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":113,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":103},"100613072","real-world-study-on-fecal-microbiota-transplantation-long-term-effectiveness-and-safety-statistics-100613072","NCT07261826","Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics","Inclusion Criteria:\n\n* Diagnosed with one of the target diseases.\n* Age ≥ 3 years.\n* Have received at least one Fecal Microbiota Transplantation (FMT) treatment.\n* Availability of complete baseline and follow-up data for analysis.\n* Provide signed informed consent (for the prospective cohort) OR consent for the use of clinical data (for the retrospective cohort).\n\nExclusion Criteria:\n\n* Clinical data is severely missing, making efficacy assessment impossible.\n* Presence of severe complications that may jeopardize safety or confound the study results.","3 Years",{"count":112,"type":21},4000,"5 Years","OBSERVATIONAL","This is a large-scale observational study aiming to evaluate the long-term effectiveness and safety of Fecal Microbiota Transplantation (FMT). FMT is a procedure that transfers gut bacteria from healthy donors to patients to restore a balanced gut microbiome.\n\nThe study will follow approximately 4,000 patients who have received or will receive FMT for conditions like recurrent C. difficile infection, inflammatory bowel disease, functional gastrointestinal disorders, and certain neurological conditions.\n\nThe main goals are to:\n\n* Assess the disease remission rates at 3 months, 1 year, and 5 years after FMT.\n* Monitor the long-term safety and any potential side effects.\n* Identify factors that may influence how well a patient responds to the treatment.\n\nThis research will use both existing patient data (retrospective cohort) and newly collected data from future patients (prospective cohort). The findings are expected to help improve and standardize FMT treatment for better patient care.",[29,117,118,119,120,121,122,123,124],"Ulcerative Colitis (UC)","Crohn Disease (CD)","Irritable Bowel Syndrome (IBS)","Chronic Functional Constipation","Chemotherapy-Induced Colitis","PD-1 Associated Enteritis","Autism Spectrum Disorder","Incomplete Intestinal Obstruction","2025-11-22",{"date":127,"type":41},"2025-12-03",{"date":129,"type":41},"2025-09-01",{"date":131,"type":21},"2028-06-30",{"name":133,"class":102},"Chen QiYi"]