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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379597
• Other study ID #: WU201711BIO
• Status: Completed
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2022
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: June 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia or bipolar disorder;

2. Patients with a weight gain of more than 10% after taking antipsychotic medications;

3. Male and female with aged 18 to 65 years;

4. PANSS total score < 60 or HAMD-17 total score= 7 and YMRS total score<5;

5. Signed the study consent for participation;

6. Not allergy to probiotics or dietary fiber medicine

7. On stable medication and dosage for at least 3 months.

Exclusion Criteria:

1. Having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;

2. Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;

3. Taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;

4. Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;

5. The routine blood tests showing abnormal renal, liver function;

6. Pregnant or lactating women.

7. No administration of any antibiotics in two mouths

Related Conditions & MeSH terms

• Bipolar Disorder
• Cognitive Dysfunction
• Disease
• Schizophrenia
• Weight Gain

Intervention

Drug:
• Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)
Bifico 840mg Bid

Dietary Supplement:
• Dietary fiber
dietary fiber compound powder 30g bid

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Lipid metabolism related blood index	Other lipid metabolism related marker such as LDL,HDL,TG, CHO (all in mmol/L)	12 weeks
Secondary	Physical exam index	Body weight related physical exam index: waist circumference,hip line (cm)	12 weeks
Secondary	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