At a glance
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A 12-weeks Study to Evaluate the Dietary Fiber and Probiotics Treatment in Prevention and Intervention of Weight-gain and Cognitive Impairment of Schizophrenia or Bipolar Disorder
In Brief
A clinical study evaluating Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral) and Dietary fiber for Schizophrenia and Bipolar Disorder. Completed, enrolled 136 participants across 1 site.
Detailed Summary
In this study, the investigators will evaluate the efficacy, safety and related mechanism of dietary fiber and probiotics alone and in combination as a add-on treatment in improving the antipsychotic induced weight gain, the cognitive impairment, and psychotic syndrome in schizophrenia or bipolar disorder patients. The study will recruit 100 schizophrenia or bipolar disorder patients who meet the criteria of DSM-5, and then randomized to 4 groups: probiotics group(PB group) dietary fiber group(FB group) probiotics plus dietary fiber group(PF group) and control group(CT group) for a 12-weeks clinical trail. The specific aims are to compare probiotics group versus controls on: 1) clinical core symptoms; 2) cognition;3)metabolic related markers.
Study Details
Timeline
Interventions
Bifico 840mg Bid
dietary fiber compound powder 30g bid