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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics Group | Experimental | Probiotics add-on treatment :(live Combined Bifidobacterium, Lactobacillus and Enterococcus Capsules, Oral), each capsule contain more then 1.0*10^7 CFU. Bifico: 840mg Bid. |
|
| Control Group | No Intervention | No probiotics or dietary fiber group. | |
| Dietary fiber Group | Experimental | Prebiotics add-on treatment: dietary fibers compound powder, 30g bid |
|
| Dietary fiber Probiotics group | Experimental | Dietary fiber and probiotics group: receiving both Bifico 840mg Bid and dietary fiber 30g bid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral) | Drug | Bifico 840mg Bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| MATRICS Consensus Cognitive Battery (MCCB) composite score | The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure before and after treatment at different follow up point. | 12 weeks |
| Body Mass Index | The body mass index (BMI) or Quetelet index is a value derived from the mass (weight) and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Positive And Negative Syndrome Scale (PANSS) | The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point. | 12 weeks |
| Lipid metabolism related blood index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DongYu Kang, M.D. | Central South University | Principal Investigator |
| SuJuan Li, M.D. | Central South University | Principal Investigator |
| RenRong Wu, M.D. Ph.D. | Central South University | Principal Investigator |
| Chenchen Liu, M.D. | Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42286534 | Derived | Xiao J, Liu C, Shao T, Kang D, Tang H, Liu F, Shi Z, Chen Y, Wu R, Zhao J, Huang J, Shao P. Circulating propionate and butyrate are associated with metabolic improvements following probiotic and dietary fiber supplementation in patients on antipsychotics: a post-hoc analysis of a randomized controlled trial. BMC Psychiatry. 2026 Jun 12. doi: 10.1186/s12888-026-08272-x. Online ahead of print. | |
| 33622382 |
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| Dietary fiber | Dietary Supplement | dietary fiber compound powder 30g bid |
|
Other lipid metabolism related marker such as LDL,HDL,TG, CHO (all in mmol/L)
| 12 weeks |
| Physical exam index | Body weight related physical exam index: waist circumference,hip line (cm) | 12 weeks |
| Hamilton Depression Scale and Young Manic Rating Scale (YMRS) | The change of total score of the Hamilton Depression Scale and the Young Manic Rating Scale (YMRS), used to measure mania and depression symptoms of bipolar disorder. | 12 weeks |
| Derived |
| Liu C, Kang D, Xiao J, Huang Y, Peng X, Wang W, Xie P, Yang Y, Zhao J, Wu R. Dietary fiber and probiotics for the treatment of atypical antipsychotic-induced metabolic side effects: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2021 Feb 23;22(1):159. doi: 10.1186/s13063-021-05123-w. |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D060825 | Cognitive Dysfunction |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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