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

NCT ID: NCT03379597

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2021-06-30

Brief 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.

Conditions

Schizophrenia; Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)

Intervention Type: DRUG

Bifico 840mg Bid

Control Group

No probiotics or dietary fiber group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Dietary fiber Group

Prebiotics add-on treatment: dietary fibers compound powder, 30g bid

Group Type: EXPERIMENTAL

Dietary fiber

Intervention Type: DIETARY_SUPPLEMENT

dietary fiber compound powder 30g bid

Dietary fiber Probiotics group

Dietary fiber and probiotics group: receiving both Bifico 840mg Bid and dietary fiber 30g bid.

Group Type: EXPERIMENTAL

Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)

Intervention Type: DRUG

Bifico 840mg Bid

Dietary fiber

Intervention Type: DIETARY_SUPPLEMENT

dietary fiber compound powder 30g bid

Interventions

Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)

Bifico 840mg Bid

Intervention Type: DRUG

Dietary fiber

dietary fiber compound powder 30g bid

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Renrong Wu

Central South University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DongYu Kang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Central South University

SuJuan Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Central South University

RenRong Wu, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Central South University

Chenchen Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Central South University

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33622382 (View on PubMed)

Other Identifiers

WU201711BIO

Identifier Type: -

Identifier Source: org_study_id