[{"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":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":42},"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":18,"type":19},15,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25,26],"Diarrhea","Enterocolitis",[25,28,26,29,30],"SER-155","Memorial Sloan Kettering Cancer Center","24-231","RECRUITING","2025-12-01",{"date":34,"type":35},"2025-12-02","ACTUAL",{"date":37,"type":35},"2025-01-24",{"date":39,"type":19},"2027-01-24",{"name":29,"class":41},"OTHER",7,""]