[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clostridium-difficile-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clostridium-difficile-infections":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,75,100],{"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":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100518415","clostridioides-difficile-infection-analyzing-clinic-evolution-and-bacterial-clearance-100518415","NCT06030245","Clostridioides Difficile Infection: Analyzing CLInic Evolution and Bacterial Clearance","Clostridioides Difficile Infection: Prospective Cohort Analyzing CLInic Evolution and Bacterial Clearance","DECLIC","Inclusion Criteria:\n\n* Patients over 18 years of age\n* Patients hospitalized in a department of GH Paris Saint-Joseph with a microbiologically documented Clostridioides difficile infection or a microbiologically documented Clostridioides difficile recurrence.\n* Patient to be treated for Clostridioides difficile infection\n* French-speaking patient\n* Patients who do not object to their participation in the study\n\nExclusion Criteria:\n\n* Patients under guardianship or curatorship\n* Patient deprived of liberty\n* Patient under court protection\n* Pregnant or breast-feeding patient","18 Years",{"count":60,"type":21},100,"OBSERVATIONAL","Clostridioides difficile (formerly Clostridium) is a bacterium found in the form of spores (resistance form) in the environment to which patients may be exposed. This bacterium used to belong to the Clostridium genus, but analysis of its 16S ribosomal RNA in 2016 led to its being distinguished from it. Once the spore has been ingested, it can germinate in vegetative form (the active form of the bacterium), taking on the appearance of a Gram-positive bacillus that will colonize the digestive microbiota. This preliminary stage of digestive colonization by the bacteria is facilitated by certain factors, notably nasogastric probing, antacids, etc. Antibiotics, for their part, disrupt the bacteria of the digestive microbiota (dysbiosis), thus facilitating the implantation of C. difficile. Certain strains (known as toxigenic) will produce the main virulence factors: toxins A (TcdA) and B (TcdB) ± a third toxin (binary toxin or CDT), and thus cause the main clinical signs of digestive infection, particularly in patients with risk factors for C. difficile infection (progressive cancer, immunodepression, etc.).\n\nClostridioides difficile infection (CDI) is characterized by variable clinical presentations, ranging from simple watery diarrhea without colitis, which often resolves spontaneously, to severe forms with complications such as pseudomembranous colitis, intestinal perforation or septic shock, which have a very poor prognosis.\n\nManagement of this type of CDI relies mainly on the oral administration of anti-clostridium difficile antibiotics such as fidaxomicin (FDX) or vancomycin (VAN) for 10 days, as recommended by the European ESCMID, British and American IDSA guidelines. Oral metronidazole is recommended only in the absence of availability of the first two molecules (community use). Despite this treatment, one of the main characteristics of CDI is a high recurrence rate, which can reach 25% of cases. With FDX, recurrence rates appear to be lower, especially as its administration regimen is optimized. Nevertheless, its high cost is a barrier to its wider use.\n\nIn view of the high cost to the community of treating recurrences, and the reduced quality of life of patients suffering from these recurrences, which are sometimes multiple and highly incapacitating, reducing the occurrence of recurrences is a major challenge. A better understanding of the factors leading to recurrence is therefore a prerequisite for optimizing CDI prevention and treatment strategies.\n\nThe study of colonic mucosal immunity (aimed at quantifying IgA in stools) could also contribute to a better understanding of patient progress.\n\nAll these issues surrounding CDI and its management justify the setting up of a prospective cohort for the longitudinal follow-up of infected patients, enabling us to study the digestive clearance of the bacteria according to various factors, notably the digestive microbiota and the mucosal immune response.",[28],"2026-02-26",{"date":66,"type":41},"2026-03-02",{"date":68,"type":41},"2023-09-18",{"date":70,"type":21},"2027-01-17",{"name":72,"class":73},"Fondation Hôpital Saint-Joseph","OTHER",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":74},"100539989","safety-registry-of-a-fecal-microbiota-transplant-cohort-100539989","NCT06311006","Safety Registry of a Fecal Microbiota Transplant Cohort","Safety Registry of a Fecal Microbiota Transplant Cohort (COSMIC-FMT)","COSMIC-FMT","Inclusion Criteria:\n\nPatients :\n\n* Adult patient with an indication for FMT for CDI (severe refractory CDI, recurrent CDI);\n* Informed written consent\n\nDonors:\n\n* Adult (18 years or older)\n* Informed Written consent\n\nExclusion Criteria:\n\n* insufficient level of understanding of written and spoken French language",true,{"count":85,"type":21},305,"Clostridium difficile infection (CDI) is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea. Recurrent forms are a major problem with this infection. The use of fecal microbiota transplantation (FMT), FMT appears in the most recent European and North American recommendations.\n\nThere is no cohort or multicenter registry in France prospectively collecting FMTs, the methods used, their efficacy and side effects. Likewise, there is no prospective collection focused on the cohort of stool donors. A large national cohort of patients who have undergone FMT as part of routine care as well as donors, is essential for evaluating the safety of FMT.",[28],[89,90],"Clostridium Difficile Infection","Fecal microbiota transplantation","2025-06-19",{"date":93,"type":41},"2025-06-25",{"date":95,"type":41},"2021-01-04",{"date":97,"type":21},"2029-01-04",{"name":99,"class":73},"Assistance Publique - Hôpitaux de Paris",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":74},"100546702","virus-as-treatment-of-c-difficile-infection-vision-100546702","NCT06398379","Virus as Treatment of C. Difficile Infection (VISION)","VISION","Inclusion Criteria:\n\n* Recurrent C. difficile infection (first or second recurrence)\n* Understand danish\n\nExclusion Criteria:\n\n* Serious food allergy (anaphylaxis)\n* Other pathogenic bacteria\u002Fvirus in stool sample prior to inclusion\n* Inability to ingest capsules\n* Gastrointestinal perforation in the 180 days prior to inclusion\n* Previous treatment with FMT og rectal bacteriotherapy in the 180 days prior to inclusion\n* Short bowel syndrome\n* Pregnancy or planning of pregnancy\n* Participation in other clinical trial in the 30 days prior to inclusion\n* Stoma\n* Other condition where FMT is considered contraindicated",{"count":108,"type":21},40,[110],"NA","Fecal Virome Transplantation (FVT) has in small studies shown benefit in the treatment of recurrent C. difficile infection.\n\nIn the VISION study we will treat patients with recurrent C. difficile infection with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Both will be following af standard treatment of antibiotics (Vancomycin)",[28],[114,115],"Fecal Virome Transplantation","Fecal Microbiota Transplantation","NOT_YET_RECRUITING","2024-04-30",{"date":119,"type":41},"2024-05-03",{"date":121,"type":21},"2024-05-01",{"date":123,"type":21},"2026-12-31",{"name":125,"class":73},"Copenhagen University Hospital, Hvidovre"]