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A 8-weeks Study to Evaluate the Probiotics Treatment in Prevention and Intervention of Weight-gain and Cognitive Impairment of First Episode Schizophrenia

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ClinicalTrials.gov Identifier: NCT03379597
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
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 probiotics as a add-on treatment in improving the antipsychotic induced weight gain, the cognitive impairment, and psychotic syndrome in first episode schizophrenia patients. The study will recruit 40 first episode schizophrenia patients who meet the criteria of DSM-5, and then randomized to probiotics group or control group for a 8-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) Not Applicable

Detailed Description:

In this study, the investigators will evaluate the efficacy, safety and related mechanism of probiotics as a add-on treatment in improving the antipsychotic induced weight gain, the cognitive impairment, and psychotic syndrome in first episode schizophrenia patients. The study will recruit 40 first episode schizophrenia patients who meet the criteria of DSM-5, and then randomized to probiotics group or control group(20 patients per arm) for a 8-weeks clinical trail. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8week. 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) probiotics may improve cognitive impairment of patients with schizophrenia; 2) probiotics could prevent the cognitive decline of patients with schizophrenia; 3)probiotics may prevent the antipsychotics induced weight gain in patients with schizophrenia.4)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 : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 8-weeks Study to Evaluate the Probiotics Treatment in Prevention and Intervention of Weight-gain and Cognitive Impairment of First Episode Schizophrenia
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotics Group

Probiotics treatment :(live Combined Bifidobacterium, Lactobacillus and Enterococcus Capsules, Oral), each capsule contain more then 1.0*10^7 CFU.

Bifico: 210mg Bid.

Drug: Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)
Bifico 420mg Bid

No Intervention: Control Group
Non-probiotics group



Primary Outcome Measures :
  1. MATRICS Consensus Cognitive Battery (MCCB) composite score [ Time Frame: 8 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: 8 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: 8 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: 8 weeks ]
    Other lipid metabolism related marker such as LDL,HDL,TG, CHO (all in mmol/L)

  3. Physical exam index [ Time Frame: 8 weeks ]
    Body weight related physical exam index: waist circumference,hip line (cm)



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;
  2. Duration of illness less than 3 years with current symptoms exacerbation;
  3. Male and female with aged 18 to 65 years;
  4. PANSS total score < 60;
  5. Signed the study consent for participation;
  6. No allergy to probiotics medicine

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 a mouth

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. +86 13787142461 dy.kang@outlook.com

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    dy.kang@outlook.com   
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
Study Chair: RenRong Wu, M.D. Ph.D. Central South University

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Responsible Party: Renrong Wu, Central South University
ClinicalTrials.gov Identifier: NCT03379597     History of Changes
Other Study ID Numbers: WU201711BIO
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

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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

Additional relevant MeSH terms:
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Body Weight Changes
Body Weight
Schizophrenia
Cognitive Dysfunction
Bipolar Disorder
Weight Gain
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Bipolar and Related Disorders
Signs and Symptoms