Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 cognitive impairment, gastrointestinal function, and metabolic disorders in schizophrenia patients, through genotype identification, psychopathology, neuropsychology, biochemical evaluation and other methods.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: BaoJi Rehabilitation Hospital; HanZhong Psychiatric Hospital; WeiNan Psychiatry Hospital; Xiangyang Central Hospital; Xianyang Central Hospital
• Treatments: Antipsychotic Agents

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)