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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03379597
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Renrong Wu, Central South University

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Drug: Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral) Dietary Supplement: Dietary fiber Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Lipid metabolism related blood index [ Time Frame: 12 weeks ]
    Other lipid metabolism related marker such as LDL,HDL,TG, CHO (all in mmol/L)

  3. Physical exam index [ Time Frame: 12 weeks ]
    Body weight related physical exam index: waist circumference,hip line (cm)

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379597


Contacts
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Contact: Dongyu Kang, M.D. +8613787142461 kangdongyu@csu.edu.cn

Locations
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China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: DongYu Kang, M.D.    +86 13787142461    kangdongyu@csu.edu.cn   
Sponsors and Collaborators
Central South University
Investigators
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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
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Responsible Party: Renrong Wu, Central South University
ClinicalTrials.gov Identifier: NCT03379597    
Other Study ID Numbers: WU201711BIO
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Renrong Wu, Central South University:
Schizophrenia
probiotics
cognitive impairment
Metabolic syndrome
clinical trail
Efficacy
Safety
Dietary fiber
Bipolar Disorder
Additional relevant MeSH terms:
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Disease
Weight Gain
Schizophrenia
Cognitive Dysfunction
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Bipolar and Related Disorders
Body Weight Changes
Body Weight
Signs and Symptoms