[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sheppard Pratt Health System\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"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":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100379924","phase-2-synbiotic-compound-to-reduce-symptoms-of-schizophrenia-100379924",false,"NCT04226898","Synbiotic Compound to Reduce Symptoms of Schizophrenia","A Double-Blind Placebo-Controlled Trial of the Synbiotic Compound Probio-Tec ABCG for Schizophrenia Patients With and Without Elevated Markers of Gastrointestinal Inflammation","Inclusion Criteria:\n\n* Age 18-65, inclusive.\n* Capacity for written informed consent.\n* Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder (APA 2013) as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5).\n* Outpatient at the time of enrollment.\n* Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (Kay et al., 1987) (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit.\n* Receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days.\n* Proficient in the English language.\n\nExclusion Criteria:\n\n* DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous versions of the DSM.\n* Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, liver disease, renal failure, any diagnosis of cancer undergoing active treatment.\n* A primary immunodeficiency condition such as HIV infection, or undergoing cancer chemotherapy, or receiving systemic corticosteroids, methotrexate or monoclonal antibodies for treatment of an autoimmune disorder.\n* History of IV drug use.\n* DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within the last three months prior to the screening visit. If the patient has a positive drug toxicity screen at the time of visit 1 (screening) further evaluation by the investigator will be done of the substance use to determine eligibility.\n* Participated in any investigational drug trial in the past 30 days.\n* Pregnant or planning to become pregnant during the study period.\n* Receipt of antibiotic medication within the 14 days prior to visit 2 (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics). Of note, patients on antibiotic may be re-screened once the minimum duration of time since antibiotics use has been met.\n* Current and regular use of a probiotic and or prebiotic supplement within the past 2 weeks. Of note, patients taking prebiotic or probiotic supplements may be re-screened.\n* Documented inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or celiac disease","ALL","18 Years","65 Years",{"count":20,"type":21},68,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to determine if taking a synbiotic supplement versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.",[27,28],"Schizophrenia","Schizoaffective Disorder",[27,28,30,31],"Synbiotics","Synbiotic","RECRUITING","2026-04-01",{"date":35,"type":36},"2026-04-07","ACTUAL",{"date":38,"type":36},"2022-02-21",{"date":40,"type":21},"2027-12",{"name":42,"class":43},"Sheppard Pratt Health System","OTHER",""]