Clinical trial NCT04291469: Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia
Official title: A Prospective, Randomized, Controlled Multicenter Trial of Probiotics and Prebiotics to Improve the Efficacy of Antipsychotics in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Probiotics
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: BaoJi Rehabilitation Hospital
name: Xiangyang Central Hospital
name: WeiNan Psychiatry Hospital
name: HanZhong Psychiatric Hospital
First posted: 2020-03-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 and 12-weeks follow-up period. In addition to probiotics, prebiotic or maltodextrin interventions, in the meantime, all participants will also use one of the prescribed antipsychotics medications. Clinical efficacy and safety assessment will be done at baseline, clinical trail and follow-up period. The specific aims are to evaluate these tips: 1) psychotic syndrome; 2) cognition; 3) Gastrointestinal function; 4) inflammatory and metabolic related markers. Psychotic syndrome will be measured by the Positive and Negative Syndrome Scale. Cognitive function will be assessed by the MATRICS Consensus Cognitive Battery. Gastrointestinal function will be assessed by gastrointestinal symptom assessment scale (GSRS). Biological samples also will be collected, and stored to research Intestinal inflammation, intestinal permeability, intestinal flora and other indicators.

Eligibility 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)

Primary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) Score from week0 to week26
timeFrame: 26weeks(week0 to week26)
Secondary outcomes:
measure: Change in MATRICS Consensus Cognitive Battery(MCCB) Score from week1 to week26
timeFrame: week26(week1 to week26 )
measure: Gastrointestinal symptom rating scale (GSRS)
timeFrame: week26 (week1 to week26)
measure: Serum inflammatory factors-TH-1
timeFrame: week26(week1 to week26)
measure: Serum inflammatory factors-TH-2
timeFrame: week26(week1 to week26)
measure: Serum inflammatory factors-TH-17
timeFrame: week26(week1 to week26)
measure: Serum inflammatory factors-Interleukin-1
timeFrame: week26(week1 to week26)
measure: Serum inflammatory factors-Interleukin-2
timeFrame: week26(week1 to week26)
measure: Serum inflammatory factors-Interleukin-6
timeFrame: week26(week1 to week26)
measure: Serum inflammatory factors-Interleukin-10
timeFrame: week26(week1 to week26)
measure: Serum inflammatory factors-Interleukin-17
timeFrame: week26(week1 to week26)
measure: Serum inflammatory factors-TNF-a
timeFrame: week26(week1 to week26)
measure: Fecal intestinal flora
timeFrame: week26 (week1 to week26)
measure: Serum intestinal permeability index-FABP2
timeFrame: week26(week1 to week26)
measure: Serum intestinal permeability index-sCD14
timeFrame: week26(week1 to week26)
measure: Serum intestinal permeability index-LBP
timeFrame: week26(week1 to week26)
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiao tong University
state: Shanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Xiancang Ma, M.D.
role: STUDY_CHAIR
References: