[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479763":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":49,"responsibleParty":68,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":43,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":43,"overallStatus":52,"whyStopped":43,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Study Med","ACTIVE_COMPARATOR","Participants randomized to active study medication will mix 4g of powder prebiotic with water, 3 times a day for 12 weeks.",[13],"Dietary Supplement: Prebiotic",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants randomized to active study medication will mix 4g of powder placebo with water, 3 times a day for 12 weeks.",[19],"Dietary Supplement: Placebo Prebiotic",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Prebiotic","Prebiotin® is a fine, white to slightly yellow powder, which is mixed into water and has a slightly sweet taste.",[9],[27],"Prebiotin®",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo Prebiotic","Placebo prebiotic mixed into water",[15],[33],"maltodextrin",[35],{"name":36,"affiliation":5,"role":37},"Robert Buchanan, M.D.","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Matt Glassman","CONTACT","410-402-6411",null,"MGlassman@som.umaryland.edu",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Jennifer Zaranski, MA","410-402-6060","jzaranski@som.umaryland.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Maryland Psyciatric Research Center","RECRUITING","Catonsville","Maryland","21228","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-76.73192,39.27205,{"lat":62,"lon":61},[65,66,67],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},{"name":36,"role":37,"phone":43,"phoneExt":43,"email":43},{"type":37,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Robert Buchanan","Chief, Maryland Psychiatric Research Center, Outpatient Research Program",[72],{"name":73,"class":74},"National Center for Complementary and Integrative Health (NCCIH)","NIH","100479763","prebiotic-treatment-in-people-with-schizophrenia-100479763",false,"NCT05527210","Prebiotic Treatment in People With Schizophrenia","FOCIS","Inclusion Criteria:\n\n1. DSM-5 diagnosis of schizophrenia or schizoaffective disorder;\n2. Age 18-60 years;\n3. Considered clinically stable by the treating psychiatrist;\n4. Currently treated with an antipsychotic, with no dose changes in last 14 days;\n5. Ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent;\n6. BMI ≤ 40\n\nExclusion Criteria:\n\n1. Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol\n2. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes\n3. Intellectual disability\n4. Acute antibiotic use\n5. Immune therapy within the last three months\n6. Prebiotic or probiotic treatment within the last three months\n7. Inability to understand English\n8. Inability to cooperate with study procedures\n9. Pregnant or lactation secondary to pregnancy\n10. Participants who meet DSM 5 criteria for alcohol or substance misuse (except caffeine and nicotine) within the last 3 months will be excluded. Participants who meet DSM 5 criteria for marijuana misuse - mild will be included in the study.","ALL","18 Years","60 Years",{"count":86,"type":87},60,"ESTIMATED","INTERVENTIONAL",[90],"NA","The proposed project is based on the observation that schizophrenia is characterized by a chronic pro-inflammatory state, which contributes to the severity of a number of the clinical manifestations of the illness, including cognitive impairments, the treatment of which represents a critically important unmet therapeutic need.",[93,94],"Schizophrenia","Schizoaffective Disorder","2026-03-05",{"date":97,"type":98},"2026-03-09","ACTUAL",{"date":100,"type":98},"2023-01-25",{"date":102,"type":87},"2026-12-31",{"name":5,"class":6},1]