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
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Weight Gain; Schizophrenia; Cognitive Dysfunction; Bipolar Disorder
Study type: Interventional

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.
    

Detailed description: 
      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 (20 patients per
      arm) for a 12-weeks clinical trail. Clinical efficacy and safety assessment will be done at
      screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare probiotics
      group versus controls on: 1) clinical core symptoms; 2) cognition; 3) metabolic related
      markers. Biological samples also will be collected, and stored to research related
      mechanisms. Clinical symptoms will be measured by the Positive and Negative Syndrome Scale,.
      Cognitive function will be assessed by the MATRICS Consensus Cognitive Battery.

      The investigators hypothesize that: 1) dietary fiber and probiotics may improve cognitive
      impairment of patients with schizophrenia; 2) dietary fiber and probiotics could prevent the
      cognitive decline of patients with schizophrenia; 3)dietary fiber and probiotics may prevent
      the antipsychotics induced weight gain in patients with schizophrenia.4)dietary fiber and
      probiotics may alter oxidative stress indexes or inflammatory biomarkers thus influence the
      oxidative and inflammatory mechanism.
    

Intervention name(s): Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral); Dietary fiber
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Bifico 840mg Bid; dietary fiber compound powder 30g bid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; probiotics; cognitive impairment; Metabolic syndrome; clinical trail; Efficacy; Safety; Dietary fiber; Bipolar Disorder