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

April 18, 2023 updated by: Renrong Wu, Central South University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital Of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)
Bifico 840mg Bid
No Intervention: Control Group
No probiotics or dietary fiber group.
Experimental: Dietary fiber Group
Prebiotics add-on treatment: dietary fibers compound powder, 30g bid
Dietary supplement: Dietary fiber
dietary fiber compound powder 30g bid
Experimental: Dietary fiber Probiotics group
Dietary fiber and probiotics group: receiving both Bifico 840mg Bid and dietary fiber 30g bid.
Drug: Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)
Bifico 840mg Bid
Dietary supplement: Dietary fiber
dietary fiber compound powder 30g bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MATRICS Consensus Cognitive Battery (MCCB) composite score
Time Frame: 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.
12 weeks
Body Mass Index
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive And Negative Syndrome Scale (PANSS)
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Other lipid metabolism related marker such as LDL,HDL,TG, CHO (all in mmol/L)
12 weeks
Physical exam index
Time Frame: 12 weeks
Body weight related physical exam index: waist circumference,hip line (cm)
12 weeks
Hamilton Depression Scale and Young Manic Rating Scale (YMRS)
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2017

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WU201711BIO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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