[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"enterocolitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:enterocolitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":43},"100577651","phase-1-a-study-of-ser-155-to-treat-diarrhea-in-people-on-immunotherapy-100577651",false,"NCT06801067","A Study of SER-155 to Treat Diarrhea in People on Immunotherapy","A Single-Arm, Open-Label, Phase 1 Study to Assess Safety and Preliminary Efficacy of Cultivated Multi-Strain Live Bacterial Therapeutic SER-155 for First-Line Treatment of Immunotherapy-Related Enterocolitis","Inclusion Criteria:\n\n* Age \\> 18 years\n* Receipt of ICI (single-agent or combination) within the 180 days preceding screening.\n\nConcurrent treatment with cytotoxic chemotherapy or other tumor-directed agents is permitted.\n\n* Grade 2 - 3 diarrhea (i.e., increase of at least 4 bowel movements a day above baseline during the screening window), deemed by the treating provider as likely related to ICI therapy, with or without concomitant symptoms of grade 1 - 2 colitis (e.g.\n\nabdominal pain, bloody or mucoid stools)\n\n* Able to swallow oral medication\n* Individuals of childbearing potential willing to use a highly effective method of contraception (failure rate of \\\u003C1% per year when used consistently and correctly) for 30 days after the last dose of SER-155.\n* Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment.\n\nExclusion Criteria:\n\n* Active GI infection, including untreated viral, bacterial or fungal cause(s) of diarrhea.\n* Received immunosuppressive therapies for suspected or confirmed irEC, including systemic corticosteroids (either oral or intravenous) and\u002For infliximab, vedolizumab or ustekinumab\n* Grade 3 colitis symptoms, i.e. severe abdominal pain or peritoneal signs\n* Admitted to the hospital for irEC\n* Prednisone (or steroid equivalent) dose \\> 10 mg a day for a non-GI irAE at time of screening\n* Pre-existing inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or microscopic colitis\n* Pregnant or lactating women\n* Any condition that requires ongoing prophylactic or therapeutic antibacterial antibiotics\n* Severe neutropenia, as defined by an absolute neutrophil count (ANC) \\\u003C 500 cells\u002Fmm\\^3, at time of screening\n* Treatment with investigational medications used for diarrhea\u002Fcolitis treatment and microbiome therapeutics within 30 days prior to enrollment\n* Known allergy or intolerance to oral vancomycin\n* Unable to comply with the protocol requirements\n* Any condition that in the opinion of the investigator may increase the risk of study participation and\u002For may interfere with the interpretation of study results","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to find out whether SER-155 may be a safe first treatment that causes few or mild side effects for people due to irEC.",[26,27],"Diarrhea","Enterocolitis",[26,29,27,30,31],"SER-155","Memorial Sloan Kettering Cancer Center","24-231","RECRUITING","2025-12-01",{"date":35,"type":36},"2025-12-02","ACTUAL",{"date":38,"type":36},"2025-01-24",{"date":40,"type":20},"2027-01-24",{"name":30,"class":42},"OTHER",7]