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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Body Mass Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia or bipolar disorder;
- •Patients with a weight gain of more than 10% after taking antipsychotic medications;
- •Male and female with aged 18 to 65 years;
- •PANSS total score < 60 or HAMD-17 total score≤ 7 and YMRS total score<5;
- •Signed the study consent for participation;
- •Not allergy to probiotics or dietary fiber medicine
- •On stable medication and dosage for at least 3 months.
排除标准
- •Having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;
- •Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
- •Taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;
- •Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
- •The routine blood tests showing abnormal renal, liver function;
- •Pregnant or lactating women.
- •No administration of any antibiotics in two mouths
研究组 & 干预措施
Probiotics Group
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.
干预措施: Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral) (Drug)
Dietary fiber Group
Prebiotics add-on treatment: dietary fibers compound powder, 30g bid
干预措施: Dietary fiber (Dietary Supplement)
Dietary fiber Probiotics group
Dietary fiber and probiotics group: receiving both Bifico 840mg Bid and dietary fiber 30g bid.
干预措施: Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral) (Drug)
Dietary fiber Probiotics group
Dietary fiber and probiotics group: receiving both Bifico 840mg Bid and dietary fiber 30g bid.
干预措施: Dietary fiber (Dietary Supplement)
结局指标
主要结局
Body Mass Index
时间窗: 12 weeks
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.
MATRICS Consensus Cognitive Battery (MCCB) composite score
时间窗: 12 weeks
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.
次要结局
- Physical exam index(12 weeks)
- Lipid metabolism related blood index(12 weeks)
- Hamilton Depression Scale and Young Manic Rating Scale (YMRS)(12 weeks)
- Positive And Negative Syndrome Scale (PANSS)(12 weeks)
研究者
Renrong Wu
Central South University
Central South University
