Title
Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia
A Prospective, Randomized, Controlled Multicenter Trial of Probiotics and Prebiotics to Improve the Efficacy of Antipsychotics in Patients With Schizophrenia
Phase
N/ALead Sponsor
Jiao Tong UniversityStudy Type
InterventionalStatus
RecruitingIndication/Condition
SchizophreniaIntervention/Treatment
Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables) [bifidobacterium animalis (12539), maltodextrin (907)] Prebiotics (Combined inulin and maltodextrin tables) [inulin (39989), maltodextrin (907)] maltodextrinStudy Participants
200In this study, investigators will evaluate the efficacy and related mechanism of probiotics and prebiotics as an add-on treatment in improving the antipsychotic induced psychotic syndrome, the cognitive impairment, gastrointestinal function, and metabolic disorders in schizophrenia patients, through genotype identification, psychopathology, neuropsychology, biochemical evaluation and other methods.
The study will recruit 210 schizophrenia patients who meet the criteria of DSM-4, and then randomized to 3 groups: control group, probiotics group and prebiotics group for a 14-weeks clinical trail and 12-weeks follow-up period. In addition to probiotics, prebiotic or maltodextrin interventions, in the meantime, all participants will also use one of the prescribed antipsychotics medications. Clinical efficacy and safety assessment will be done at baseline, clinical trail and follow-up period. The specific aims are to evaluate these tips: 1) psychotic syndrome; 2) cognition; 3) Gastrointestinal function; 4) inflammatory and metabolic related markers. Psychotic syndrome will be measured by the Positive and Negative Syndrome Scale. Cognitive function will be assessed by the MATRICS Consensus Cognitive Battery. Gastrointestinal function will be assessed by gastrointestinal symptom assessment scale (GSRS). Biological samples also will be collected, and stored to research Intestinal inflammation, intestinal permeability, intestinal flora and other indicators.
The probiotic compound will consist of tables containing approximately 10^9 colony forming units of the probiotic organisms, Lactobacillus and Bifidobacteria lactis strain，mixed maltodextrin(oral, daily for 14 weeks).
The prebiotic compound will consist of tables containing inulin and maltodextrin (oral,daily for 14 weeks)
Maltodextrin tables (oral,daily for 14 weeks)
Identical-appearing Placebo (maltodextrin tables) ,oral, daily for 14 weeks
Combined Bifidobacteria+lactobacillus+maltodextrin tables, each table contain more than 1.0*10^9 colony forming units, oral, daily for 14 weeks
Combined inulin+maltodextrin tables, oral, daily for 14 weeks
Inclusion Criteria: Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia Duration of illness 5 years, Subjects are currently receiving first-line recommended antipsychotic medication The total PANSS score ≥60, containing at least three positive or negative items with scores of 3 or more at screening Junior high school or above Capacity for written informed consent. Exclusion Criteria: Pregnant or lactating women Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, abnormal liver function, renal failure, immunodeficiency diseases, cancer, or gastrointestinal diseases ( inflammatory bowel disease or celiac disease, except functional constipation) Subjects had acute or chronic infections or are taking anti-inflammatory drugs and cortisol hormones. Receipt of antibiotic medication within the previous 1 month. Other neuropsychiatric disorders (organic diseases of the central nervous system, a mental disorder caused by a physical disease or psychoactive substance, mental retardation). Having history of substance dependence or abuse，including alcohol BMI is not within the normal range (18.5 to 23.9)
