[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-graft-versus-host-disease-in-intestine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-graft-versus-host-disease-in-intestine":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100640701","phase-1-fmt-for-pediatric-sr-agvhd-100640701",false,"NCT07602751","FMT for Pediatric SR-aGVHD","Fecal Microbiota Transplantation for the Treatment of Steroid-refractory Graft-versus-host Disease.","Inclusion Criteria:\n\n* Diagnosis of hematological disease, malignant or non-malignant;\n* Patients undergoing allogeneic stem cell transplantation from a familial or unrelated donor;\n* Presence of acute GVHD with intestinal involvement (grade II-IV), steroid-resistant (i.e., with progression after 3 days of high-dose steroid therapy (methylprednisolone \\> 2 mg\u002Fkg), no response after 7 days, progression during steroid tapering, or failure to achieve remission on day 28 from the start of steroid therapy), for those who have no indication for other second- or third-line therapies;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Presence of concurrent bacterial infections requiring systemic antibiotic therapy;\n* Positivity for anti-HIV or anti-HCV antibodies, or for HbsAg with HBV-DNA positive by PCR;\n* Presence of severe mucositis;\n* History of chronic inflammatory bowel disease.","ALL","3 Months","25 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a pilot, prospective, non-profit, multicenter, uncontrolled, open-label study to evaluate the safety and feasibility of FMT in patients aged between 3 months and 25 years suffering from acute intestinal GVHD resistant to conventional steroid therapy.\n\nEligible patients will receive 1-3 FMT via naso-jejunal tube or endoscopy.",[28],"Acute Graft Versus Host Disease in Intestine",[30],"graft-versus-host disease","NOT_YET_RECRUITING","2026-05-19",{"date":34,"type":35},"2026-05-22","ACTUAL",{"date":37,"type":21},"2026-05-18",{"date":39,"type":21},"2029-05",{"name":41,"class":42},"Bambino Gesù Hospital and Research Institute","OTHER",3,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":4,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":60,"locationsCount":63},"100421523","early-access-program-with-maat013-in-steroid-refractory-acute-gastrointestinal-graft-versus-host-disease-100421523","NCT04768907","Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease","ATLAS","Inclusion Criteria:\n\n* Age \\> or = 18\n* Grade III-IV gastro intestinal acute graft versus host disease with or without involvement of other organs:\n* patients resistant to corticosteroid (CS) and resistant to one or multiple lines of treatments\n* patients who cannot tolerate CS tapering, i.e., begin of CS at 2.0 mg\u002Fkg\u002Fd, demonstrate response, but show disease progress before a 50% decrease from the initial starting dose of CS is achieved.\n* acute GVHD with overlap syndrome\n\nExclusion Criteria:\n\n* Active uncontrolled infection\n* Relapsed\u002Fpersistent malignancy requiring rapid immune suppression withdrawal\n* Current or past veno-occlusive disease or other uncontrolled complication\n* Absolute neutrophil count \\\u003C500\u002FµL for 3 consecutive days. Use of growth factor supplementation is allowed\n* Absolute platelet count \\\u003C 10 000\u002FµL. Use of platelet infusion is allowed\n* Current or past evidence of toxic megacolon, bowel obstruction or gastrointestinal perforation\n* Known allergy or intolerance to trehalose or maltodextrin\n* Pregnancy\n* Breastfeeding","18 Years","EXPANDED_ACCESS","MaaT013 is still in clinical development phase and is not approved yet for marketing in any region. During the development program, MaaT Pharma has undertaken initial development with closely related product candidates, leading to the Phase II HERACLES study in which MaaT013 preliminary safety and efficacy were assessed in the context of steroid-resistant, gastrointestinal aGraft versus Host Disease (SR-GI-aGvHD). In addition, a pivotal Phase III study (ARES trial) is planned.\n\nIn the absence of medical options in patients with gastrointestinal acute GvHD refractory to multiple lines of treatment, this early access program has been implemented.",[28,55],"Steroid Refractory GVHD","AVAILABLE","2024-08-27",{"date":59,"type":35},"2024-08-28",{"name":61,"class":62},"MaaT Pharma","INDUSTRY",46]