[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100379924":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":52,"collaborators":30,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":30,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":30,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Sheppard Pratt Health System","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Synbiotic Supplement","EXPERIMENTAL","The active synbiotic supplement consists of a stick\u002Fpacket containing 4 strains of probiotic microorganisms: Lactobacillus acidophilus, LA-5® (material number 501082 FD LAK KGPharma); Lactobacillis paracasei subsp. paracasei, L. CASEI 431® (material number 684301 FD L. casei 431 HA Granulate); Lactobacillus rhamnosus, LGG® (material number 699817 FD LGG HA-W-IF); and Bifidobacterium animalis subsp. lactis, BB-12® (material number 699813 FD BB-12 HA-W-IF). In addition, the stick\u002Fsachet contains 5 g inulin. The product is a powder which participants will be asked to take with liquid or food. In this arm, the participant will take 1 powder stick of the synbiotic supplement once a day for 12 weeks after a 2-week placebo run-in.",[13],"Biological: Synbiotic Supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"Inert Compound","PLACEBO_COMPARATOR","The inert compound placebo looks identical to the synbiotic supplement. In this arm, the participant will take 1 powder stick of the placebo daily for 12 weeks after a 2 week placebo run-in.",[19],"Biological: Inert Compound",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Synbiotic supplement 1 powder stick by mouth daily",[9],[26],"Probio-Tec® ABCG-Stick-25",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Synbiotic supplement identical placebo 1 powder stick by mouth daily",[15],null,[32],{"name":33,"affiliation":5,"role":34},"Faith Dickerson, PhD, MPH","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Emily Katsafanas","CONTACT","410-938-4360","ekatsafanas@sheppardpratt.org",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":30,"geoPoint":30,"contacts":49},"RECRUITING","Batlimore","Maryland","21285","United States","US",[50],{"name":37,"role":38,"phone":51,"phoneExt":30,"email":40},"443-608-3300",{"type":34,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Faith Dickerson","Principal Investigator, Stanley Research Program","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":66,"type":67},68,"ESTIMATED","INTERVENTIONAL",[70],"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.",[73,74],"Schizophrenia","Schizoaffective Disorder",[73,74,76,77],"Synbiotics","Synbiotic","2026-04-01",{"date":80,"type":81},"2026-04-07","ACTUAL",{"date":83,"type":81},"2022-02-21",{"date":85,"type":67},"2027-12",{"name":5,"class":6},1]