Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Dietary Supplement: maltodextrinDietary Supplement: Prebiotics (Combined inulin and maltodextrin tables)
- Registration Number
- NCT04291469
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group maltodextrin Identical-appearing Placebo (maltodextrin tables) ,oral, daily for 14 weeks Prebiotics group Prebiotics (Combined inulin and maltodextrin tables) Combined inulin+maltodextrin tables, oral, daily for 14 weeks Probiotics group Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables) Combined Bifidobacteria+lactobacillus+maltodextrin tables, each table contain more than 1.0\*10\^9 colony forming units, oral, daily for 14 weeks
- Primary Outcome Measures
Name Time Method Change in Positive and Negative Syndrome Scale (PANSS) Score from week0 to week26 26weeks(week0 to week26) The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The clinical efficacy was evaluated by its score reduction rate, with the total score reduction rate ≥75% as recovery, 50% \~ 74% as significant improvement, 25% \~ 49% as improvement, and \<25% as invalid. improvement, significant improvement and recovery add up to apparent effect.
- Secondary Outcome Measures
Name Time Method Serum inflammatory factors-TNF-a week26(week1 to week26) Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --TNF-a(tumor necrosis factor-a,interferon).
Fecal intestinal flora week26 (week1 to week26) The number of lactobacillus and bifidobacterium flora will be assessed; The species and abundance of intestinal flora were identified by 16SrRNA.
Serum inflammatory factors-Interleukin-1 week26(week1 to week26) Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--Interleukin-1
Serum inflammatory factors-Interleukin-17 week26(week1 to week26) Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-17
Serum intestinal permeability index-LBP week26(week1 to week26) Change of Serum intestinal permeability index will be assessed during the the double-blind phase-LBP
Change in MATRICS Consensus Cognitive Battery(MCCB) Score from week1 to week26 week26(week1 to week26 ) Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) score from the start of Trial period to the end of the follow-up phase; Cognitive performance is measured by the MATRICS Consensus Cognitive Battery composite score in participants.
Gastrointestinal symptom rating scale (GSRS) week26 (week1 to week26) Gastrointestinal function will be assessed during the screening stage，week 4, week 8, week 12, week 14 of treatment stage and once every 4 weeks of follow-up stage through Gastrointestinal symptom rating scale (GSRS); The score reduction of GSRS≥25% was associated with improvement in gastrointestinal function.
Serum inflammatory factors-TH-1 week26(week1 to week26) Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --TH-1
Serum inflammatory factors-TH-2 week26(week1 to week26) Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--TH-2
Serum inflammatory factors-TH-17 week26(week1 to week26) Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--TH-17
Serum inflammatory factors-Interleukin-2 week26(week1 to week26) Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-2
Serum inflammatory factors-Interleukin-6 week26(week1 to week26) Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-6
Serum inflammatory factors-Interleukin-10 week26(week1 to week26) Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-10
Serum intestinal permeability index-FABP2 week26(week1 to week26) Change of Serum intestinal permeability index will be assessed during the the double-blind phase- FABP2
Serum intestinal permeability index-sCD14 week26(week1 to week26) Change of Serum intestinal permeability index will be assessed during the the double-blind phase-sCD14
Trial Locations
- Locations (1)
First Affiliated Hospital of Xi'an Jiao tong University
🇨🇳Xi'an, Shanxi, China