Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BaoJi Rehabilitation Hospital | UNKNOWN |
| Xiangyang Central Hospital | OTHER |
| WeiNan Psychiatry Hospital | UNKNOWN |
| HanZhong Psychiatric Hospital |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Identical-appearing Placebo (maltodextrin tables) ,oral, daily for 14 weeks |
|
| Probiotics group | Experimental | Combined Bifidobacteria+lactobacillus+maltodextrin tables, each table contain more than 1.0*10^9 colony forming units, oral, daily for 14 weeks |
|
| Prebiotics group | Experimental | Combined inulin+maltodextrin tables, oral, daily for 14 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables) | Drug | The probiotic compound will consist of tables containing approximately 10^9 colony forming units of the probiotic organisms, Lactobacillus and Bifidobacteria lactis strain，mixed maltodextrin(oral, daily for 14 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Score from 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. | 26weeks(week0 to week26) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MATRICS Consensus Cognitive Battery(MCCB) Score from 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. | week26(week1 to week26 ) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YingYing Dong, M.D. | Contact | 0086-13992808564 | 406022725@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiancang Ma, M.D. | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiao tong University | Recruiting | Xi’an | Shanxi | 710061 | China |
If necessary, part of the data can be obtained through the project leader.
Not provided
Not provided
Not provided
Not provided
Not provided
| UNKNOWN |
Not provided
Not provided
Not provided
Not provided
|
|
| Prebiotics (Combined inulin and maltodextrin tables) | Dietary Supplement | The prebiotic compound will consist of tables containing inulin and maltodextrin (oral,daily for 14 weeks) |
|
| maltodextrin | Dietary Supplement | Maltodextrin tables (oral,daily for 14 weeks) |
|
| Gastrointestinal symptom rating scale (GSRS) | 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. | week26 (week1 to week26) |
| Serum inflammatory factors-TH-1 | Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --TH-1 | week26(week1 to week26) |
| Serum inflammatory factors-TH-2 | Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--TH-2 | week26(week1 to week26) |
| Serum inflammatory factors-TH-17 | Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--TH-17 | week26(week1 to week26) |
| Serum inflammatory factors-Interleukin-1 | Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--Interleukin-1 | week26(week1 to week26) |
| Serum inflammatory factors-Interleukin-2 | Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-2 | week26(week1 to week26) |
| Serum inflammatory factors-Interleukin-6 | Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-6 | week26(week1 to week26) |
| Serum inflammatory factors-Interleukin-10 | Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-10 | week26(week1 to week26) |
| Serum inflammatory factors-Interleukin-17 | Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-17 | week26(week1 to week26) |
| Serum inflammatory factors-TNF-a | Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --TNF-a(tumor necrosis factor-a,interferon). | week26(week1 to week26) |
| Fecal intestinal flora | The number of lactobacillus and bifidobacterium flora will be assessed; The species and abundance of intestinal flora were identified by 16SrRNA. | week26 (week1 to week26) |
| Serum intestinal permeability index-FABP2 | Change of Serum intestinal permeability index will be assessed during the the double-blind phase- FABP2 | week26(week1 to week26) |
| Serum intestinal permeability index-sCD14 | Change of Serum intestinal permeability index will be assessed during the the double-blind phase-sCD14 | week26(week1 to week26) |
| Serum intestinal permeability index-LBP | Change of Serum intestinal permeability index will be assessed during the the double-blind phase-LBP | week26(week1 to week26) |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C100843 | Lacteol |
| D056692 | Prebiotics |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
Not provided
Not provided