[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clostridium-difficile\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clostridium-difficile":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,81],{"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":64,"conditions":65,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100521570","phase-1-fmt-in-patients-with-recurrent-cdi-and-ulcerative-colitis-single-infusion-versus-sequential-approach-100521570","NCT06071312","FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach","Fecal Microbiota Transplantation in Patients With Recurrent Clostridioides Cifficile Infection and Ulcerative Colitis: Single Infusion Versus Sequential Approach","Inclusion Criteria:\n\n* Age ≥18 years;\n* Active UC (partial Mayo score ≥2);\n* Relapsing infection of C. difficile;\n* Ability to express consent for inclusion in the study.\n* Indication, in the clinical practice setting, for fecal microbiota transplantation from a healthy donor for recurrent CDI\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years;\n* Other gastrointestinal infections, excluding C. difficile;\n* Known gastrointestinal diseases, other than UC, in active stage (e.g., infectious gastroenteritis, celiac disease, irritable bowel syndrome, chronic pancreatitis, bile acid diarrhea, etc.);\n* Previous colon surgery or skin ostomy packing;\n* Food allergies;\n* Current or recent (\\\u003C2 weeks) therapy with drugs that may alter the microbiota (e.g., systemic antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin), except antibiotics against C. difficile;\n* Heart failure or heart disease with FE ≤ 30 %;\n* Severe respiratory failure;\n* Psychiatric disorders;\n* Pregnancy and lactation;\n* Inability to provide informed consent.","18 Years","75 Years",{"count":60,"type":21},64,[62,63],"PHASE1","PHASE2","Clostridioides difficile infection (CDI) is the most frequent cause of infectious diarrhea in hospitalized patients and is responsible for 20-30 % of antibiotic-associated diarrhea cases. Inflammatory bowel diseases (IBD) are associated with an higher prevalence, recurrence and severity of CDI. The prevalence of recurrent CDI in patients with IBD is 2.5 to 8 times higher than in the general population, with a cumulative lifetime risk of 10 %. The higher risk to the development of CDI in patient with IBD is directly related to the microbiome alterations that are associated with this chronic disoder. Moreover, the use of antibiotics to cure CDI further worsens the gut microbiota, triggering potentially a self-maintaining cycle and predisposes such patients to a higher risk of recurrence. In these patients, CD superinfection is associated, with an increased rate of hospitalization, length of stay, the need to modify the treatment to the underlying disease, the increase rate of colectomy, there higher mortality rate, with a net increase of health costs.\n\nNowadays, as emerged by several studies FMT has been established as a valid treatment option against recurrent CDI (rCDI), and it is recommended by international guidelines.\n\nUnfortunately, most FMT studies for rCDI have excluded patients with IBD. Recent evidence suggests that FMT is effective in patients with ulcerative colitis (UC) and concomitant rCDI, both in the treatment of the infection and in the improve of disease activity. To date, most studies evaluated the efficacy of single infusion of FMT in these patients.\n\nPreliminary data from our group suggest that a sequential approach (i.e., repeated fecal infusions) may increase the efficacy of FMT in this population. Indeed, in 18 patients with IBD, single infusion fecal resulted in eradication of rCDI in 60% of cases, whereas this outcome was achieved in 89% of cases using a sequential approach. Similar data have been demonstrated in a retrospective study by Fischer and colleagues. However, more studies are advocated to confirm these results.\n\nTherefore, our study aim to compare the efficacy of single FMT vs. sequential in the eradication of rCDI in patients with UC.",[27,66],"Ulcerative Colitis",[66,68,69],"Clostridium difficile","Fecal microbiota transplantation","2026-03-17",{"date":72,"type":41},"2026-03-19",{"date":74,"type":41},"2023-09-23",{"date":76,"type":21},"2026-09-24",{"name":78,"class":79},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100535955","dynamics-of-colonization-and-infection-by-multidrug-resistant-pathogens-in-immunocompromised-and-critically-ill-patients-100535955","NCT06258551","Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients","DYNAMITE","Inclusion Criteria:\n\n* Admission to an intensive care unit or stem cell transplant unit (for allogeneic stem cell transplantation) within previous 24 hours\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* Pregnancy\n* History of inflammatory bowel disease (Crohn's disease, ulcerative colitis)\n* Gastrointestinal derivation (colostomy, ileostomy, etc.)",true,{"count":90,"type":21},1000,"OBSERVATIONAL","The goal of this observational study is to investigate how bacterial populations from the intestine and mouth of patients change during the hospitalization period and evaluate if some populations of specific bacteria increase or decrease the risk of acquiring an infection or becoming colonized by pathogenic bacteria. Participants will have the following samples collected during enrollment: stool samples (maximum 2x\u002Fweek), blood draws (1x\u002Fweek), oral swab (1x\u002Fweek).",[94,95,27,96,97,98,99,100],"Antimicrobial Drug Resistance","Antibiotic Resistant Infection","Carbapenem-Resistant Enterobacteriaceae Infection","Extended Spectrum Beta-Lactamase Producing Bacteria Infection","Vancomycin Resistant Enterococci Infection","Carbapenem Resistant Bacterial Infection","Vancomycin-Resistant Enterococcal Infection","2024-02-06",{"date":103,"type":41},"2024-02-14",{"date":105,"type":41},"2020-12-08",{"date":107,"type":21},"2026-06",{"name":109,"class":79},"The Methodist Hospital Research Institute",2]