- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04291469
Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia
April 6, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University
A Prospective, Randomized, Controlled Multicenter Trial of Probiotics and Prebiotics to Improve the Efficacy of Antipsychotics in Patients With Schizophrenia
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: YingYing Dong, M.D.
- Phone Number: 0086-13992808564
- Email: 406022725@qq.com
Study Locations
-
-
Shanxi
-
Xi'an, Shanxi, China, 710061
- Recruiting
- First Affiliated Hospital of Xi'an Jiao Tong University
-
Contact:
- Xiancang Ma, M.D.
- Phone Number: 0086-13002951782
- Email: maxiancang@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control group
Identical-appearing Placebo (maltodextrin tables) ,oral, daily for 14 weeks
|
Maltodextrin tables (oral,daily for 14 weeks)
|
Experimental: Probiotics group
Combined Bifidobacteria+lactobacillus+maltodextrin tables, each table contain more than 1.0*10^9 colony forming units, oral, daily for 14 weeks
|
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).
Other Names:
|
Experimental: Prebiotics group
Combined inulin+maltodextrin tables, oral, daily for 14 weeks
|
The prebiotic compound will consist of tables containing inulin and maltodextrin (oral,daily for 14 weeks)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Positive and Negative Syndrome Scale (PANSS) Score from week0 to week26
Time Frame: 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.
|
26weeks(week0 to week26)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in MATRICS Consensus Cognitive Battery(MCCB) Score from week1 to week26
Time Frame: 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.
|
week26(week1 to week26 )
|
Gastrointestinal symptom rating scale (GSRS)
Time Frame: 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.
|
week26 (week1 to week26)
|
Serum inflammatory factors-TH-1
Time Frame: week26(week1 to week26)
|
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
Time Frame: week26(week1 to week26)
|
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
Time Frame: week26(week1 to week26)
|
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
Time Frame: week26(week1 to week26)
|
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
Time Frame: week26(week1 to week26)
|
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
Time Frame: week26(week1 to week26)
|
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
Time Frame: week26(week1 to week26)
|
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
Time Frame: week26(week1 to week26)
|
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
Time Frame: 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).
|
week26(week1 to week26)
|
Fecal intestinal flora
Time Frame: 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.
|
week26 (week1 to week26)
|
Serum intestinal permeability index-FABP2
Time Frame: week26(week1 to week26)
|
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
Time Frame: week26(week1 to week26)
|
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
Time Frame: week26(week1 to week26)
|
Change of Serum intestinal permeability index will be assessed during the the double-blind phase-LBP
|
week26(week1 to week26)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Xiancang Ma, M.D., First Affiliated Hospital Xi'an Jiaotong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2022
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
February 13, 2020
First Submitted That Met QC Criteria
February 27, 2020
First Posted (Actual)
March 2, 2020
Study Record Updates
Last Update Posted (Actual)
April 8, 2022
Last Update Submitted That Met QC Criteria
April 6, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJTU1AF-CRF-2019-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
If necessary, part of the data can be obtained through the project leader.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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