A 8-weeks Study to Evaluate the Probiotics Treatment in Prevention and Intervention of Weight-gain and Cognitive Impairment of First Episode Schizophrenia
|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 : December 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Bipolar Disorder||Drug: Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
- Lipid metabolism related blood index [ Time Frame: 8 weeks ]Other lipid metabolism related marker such as LDL,HDL,TG, CHO (all in mmol/L)
- Physical exam index [ Time Frame: 8 weeks ]Body weight related physical exam index: waist circumference,hip line (cm)
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
|Contact: DongYu Kang, M.D.||+86 email@example.com|
|The Second Xiangya Hospital of Central South University||Recruiting|
|Changsha, Hunan, China, 410011|
|Contact: DongYu Kang, M.D. +86 13787142461 firstname.lastname@example.org|
|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|