Status:
UNKNOWN
Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Collaborating Sponsors:
BaoJi Rehabilitation Hospital
Xiangyang Central Hospital
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
In this study, investigators will evaluate the efficacy and related mechanism of probiotics and prebiotics as an add-on treatment in improving the antipsychotic induced psychotic syndrome, the cogniti...
Detailed Description
The study will recruit 210 schizophrenia patients who meet the criteria of DSM-4, and then randomized to 3 groups: control group, probiotics group and prebiotics group for a 14-weeks clinical trail an...
Eligibility Criteria
Inclusion
- Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia
- Duration of illness 5 years, Subjects are currently receiving first-line recommended antipsychotic medication
- The total PANSS score ≥60, containing at least three positive or negative items with scores of 3 or more at screening
- Junior high school or above
- Capacity for written informed consent.
Exclusion
- Pregnant or lactating women
- Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, abnormal liver function, renal failure, immunodeficiency diseases, cancer, or gastrointestinal diseases ( inflammatory bowel disease or celiac disease, except functional constipation)
- Subjects had acute or chronic infections or are taking anti-inflammatory drugs and cortisol hormones. Receipt of antibiotic medication within the previous 1 month.
- Other neuropsychiatric disorders (organic diseases of the central nervous system, a mental disorder caused by a physical disease or psychoactive substance, mental retardation).
- Having history of substance dependence or abuse，including alcohol
- BMI is not within the normal range (18.5 to 23.9)
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04291469
Start Date
March 3 2022
End Date
December 1 2022
Last Update
April 8 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
First Affiliated Hospital of Xi'an Jiao tong University
Xi’an, Shanxi, China, 710061