[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cdi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cdi":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100557106","evaluation-of-gut-microbiota-and-its-associated-resistome-in-fmt-donors-and-recipients-due-to-recurrent-clostridiodes-difficile-infection-100557106","NCT06533800","Evaluation of Gut Microbiota and Its Associated Resistome in FMT Donors and Recipients Due to Recurrent Clostridiodes Difficile Infection","VALUTAZIONE DEL MICROBIOTA E DEL RESISTOMA NEI DONATORI E NEI RICEVENTI DI FMT IN PAZIENTI CON INFEZIONE RICORRENTE DA CLOSTRIDIOIDES DIFFICILE","MICROFMT","Inclusion criteria\n\n* patients with rCDI (\\> 18 years) to whom faecal microbiota transplantation is indicated, without other pathologies or prolonged hospitalization periods\n* donors: healthy volunteers aged between 18 and 50 years\n* Patients capable of expressing consent\n\nExclusion criteria\n\n* antibiotic therapies in the last 30 days\n* treatments with prebiotics - probiotics - postbiotics in the last 60 days\n* colonization by MDR or XDR pathogens\n* presence of pre-existing or ongoing intestinal pathologies (Inflammatory Intestinal Diseases, chronic hepatitis, celiac disease, neoplasms, previous large intestinal resections)\n* ongoing diarrhea of any origin (defined as more than 6 watery stools per day and\u002For faecal volume greater than 250 ml in 24 hours)\n* severe septic state in progress\n* for donors: drug addiction, promiscuous sexual behaviour, use of drugs that can be excreted in the faeces with potential risk for recipients","18 Years",{"count":60,"type":21},24,"OBSERVATIONAL","Caratterizzazione della composizione microbica intestinale nei donatori di FMT e nei pazienti affetti da rCDI al tempo basale e a seguito del trapianto di microbiota fecale. Negli stessi time point valutare il resistoma associato alla comunità microbica rilevata.",[32],"NOT_YET_RECRUITING","2024-07-30",{"date":67,"type":41},"2024-08-01",{"date":69,"type":21},"2024-09-15",{"date":71,"type":21},"2026-08-15",{"name":73,"class":74},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER"]