[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clostridium-difficile-diarrhea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clostridium-difficile-diarrhea":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100580585","advantages-and-disadvantages-of-toxclean-as-add-on-treatment-to-soc-in-patients-with-clostridium-difficile-associated-diarrhea-100580585",false,"NCT06839209","Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea","Pilot Study to Evaluate Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female, at the time of informed consent\n* Signed informed consent by patient, or where applicable, patient's legally authorized representative;\n* Diagnosis of recurrent CDAD, defined as those episodes of C. Difficile associated diarrhea occurring 2-8 weeks after either the symptoms resolution of a previous CDAD episode or C. difficile negativization of fecal sample.\n* Detection of C. difficile toxins by nucleic acid amplification tests (NAAT), EIA or GDH;\n* Received at least one course of adequate antibiotic therapy for CDAD (≥ 10 days of vancomycin at a dose of ≥125 mg four times per day, ≥ 10 days of metronidazole at a dose of 500mg three times per day or fidaxomixin 200mg twice a day for 10 days)\n\nExclusion Criteria:\n\n* History of C. difficile complicating inflammatory bowel disease (Crohn's disease, ulcerative colitis), or history of bowel resection surgery (other than uncomplicated appendectomy) or history of other infectious diarrhea or diarrhea of unknown etiology since the initial episode of CDAD;\n* Participants who require oral anticoagulant medications, including but not limited to warfarin and NOACs (novel oral anticoagulants);\n* Major gastrointestinal surgery within 3 months of enrollment;\n* History of swallowing difficulties, including dysphagia or odynophagia for liquids or solids;\n* Clinically immunocompromised due to any primary immune or autoimmune deficiency, as a result of chronic disease, cancer or medication used to treat these diseases\n* Consumption of the following prescription medications during the current enrollment episode: Bezlotuxamab\u002FZinplava Is pregnant or lactating Known hypersensitivity to the active principle or excipients","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a single center, randomized, exploratory clinical investigation that will evaluate the safety and efficacy of Toxclean (ABResearch srl) as add on treatment to Standard therapy in 24 patients with recurrent CDAD.\n\nEligible subjects will be adult patients with recurrent CDAD. Recurrent CDAD, for the purpose of this protocol, is defined as one or more new episode of diarrhea (Ned) within two months from the end of the SoC treatment. The objective of this pilot study is to evaluate whether 1 or 2 grams of Toxclean powder is orally administrable and well tolerated as add on treatment to SoC in patients with recurrent CDAD.",[26,27],"Clostridium; Difficile, As Cause of Disease Classified Elsewhere","Clostridium Difficile Diarrhea",[29,30,31],"clostridium difficile","clostridium","cdad","RECRUITING","2025-02-24",{"date":35,"type":36},"2025-02-26","ACTUAL",{"date":38,"type":36},"2025-01-27",{"date":40,"type":20},"2025-12-31",{"name":42,"class":43},"ABResearch S.r.l.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"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":55,"type":20},260,[57],"PHASE2","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.",[60,61,27,62],"Clostridioides Difficile Infection","Clostridium Difficile Infection","Clostridia Difficile Colitis","2024-10-22",{"date":65,"type":36},"2024-10-26",{"date":67,"type":36},"2021-06-01",{"date":69,"type":20},"2027-06-30",{"name":71,"class":72},"University of Virginia","OTHER"]