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Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)
Prebiotics (Combined inulin and maltodextrin tables)
maltodextrin
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Probiotics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiao tong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control group

Probiotics group

Prebiotics group

Arm Description

Identical-appearing Placebo (maltodextrin tables) ,oral, daily for 14 weeks

Combined Bifidobacteria+lactobacillus+maltodextrin tables, each table contain more than 1.0*10^9 colony forming units, oral, daily for 14 weeks

Combined inulin+maltodextrin tables, oral, daily for 14 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Serum inflammatory factors-TH-1
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --TH-1
Serum inflammatory factors-TH-2
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--TH-2
Serum inflammatory factors-TH-17
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--TH-17
Serum inflammatory factors-Interleukin-1
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--Interleukin-1
Serum inflammatory factors-Interleukin-2
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-2
Serum inflammatory factors-Interleukin-6
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-6
Serum inflammatory factors-Interleukin-10
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-10
Serum inflammatory factors-Interleukin-17
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-17
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).
Fecal intestinal flora
The number of lactobacillus and bifidobacterium flora will be assessed; The species and abundance of intestinal flora were identified by 16SrRNA.
Serum intestinal permeability index-FABP2
Change of Serum intestinal permeability index will be assessed during the the double-blind phase- FABP2
Serum intestinal permeability index-sCD14
Change of Serum intestinal permeability index will be assessed during the the double-blind phase-sCD14
Serum intestinal permeability index-LBP
Change of Serum intestinal permeability index will be assessed during the the double-blind phase-LBP

Full Information

First Posted
February 13, 2020
Last Updated
April 6, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
BaoJi Rehabilitation Hospital, Xiangyang Central Hospital, WeiNan Psychiatry Hospital, HanZhong Psychiatric Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04291469
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
BaoJi Rehabilitation Hospital, Xiangyang Central Hospital, WeiNan Psychiatry Hospital, HanZhong Psychiatric Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Identical-appearing Placebo (maltodextrin tables) ,oral, daily for 14 weeks
Arm Title
Probiotics group
Arm Type
Experimental
Arm Description
Combined Bifidobacteria+lactobacillus+maltodextrin tables, each table contain more than 1.0*10^9 colony forming units, oral, daily for 14 weeks
Arm Title
Prebiotics group
Arm Type
Experimental
Arm Description
Combined inulin+maltodextrin tables, oral, daily for 14 weeks
Intervention Type
Drug
Intervention Name(s)
Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)
Other Intervention Name(s)
Probiotic bacteria
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotics (Combined inulin and maltodextrin tables)
Intervention Description
The prebiotic compound will consist of tables containing inulin and maltodextrin (oral,daily for 14 weeks)
Intervention Type
Dietary Supplement
Intervention Name(s)
maltodextrin
Intervention Description
Maltodextrin tables (oral,daily for 14 weeks)
Primary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS) Score from week0 to week26
Description
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.
Time Frame
26weeks(week0 to week26)
Secondary Outcome Measure Information:
Title
Change in MATRICS Consensus Cognitive Battery(MCCB) Score from week1 to week26
Description
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.
Time Frame
week26(week1 to week26 )
Title
Gastrointestinal symptom rating scale (GSRS)
Description
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.
Time Frame
week26 (week1 to week26)
Title
Serum inflammatory factors-TH-1
Description
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --TH-1
Time Frame
week26(week1 to week26)
Title
Serum inflammatory factors-TH-2
Description
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--TH-2
Time Frame
week26(week1 to week26)
Title
Serum inflammatory factors-TH-17
Description
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--TH-17
Time Frame
week26(week1 to week26)
Title
Serum inflammatory factors-Interleukin-1
Description
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--Interleukin-1
Time Frame
week26(week1 to week26)
Title
Serum inflammatory factors-Interleukin-2
Description
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-2
Time Frame
week26(week1 to week26)
Title
Serum inflammatory factors-Interleukin-6
Description
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-6
Time Frame
week26(week1 to week26)
Title
Serum inflammatory factors-Interleukin-10
Description
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-10
Time Frame
week26(week1 to week26)
Title
Serum inflammatory factors-Interleukin-17
Description
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-17
Time Frame
week26(week1 to week26)
Title
Serum inflammatory factors-TNF-a
Description
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --TNF-a(tumor necrosis factor-a,interferon).
Time Frame
week26(week1 to week26)
Title
Fecal intestinal flora
Description
The number of lactobacillus and bifidobacterium flora will be assessed; The species and abundance of intestinal flora were identified by 16SrRNA.
Time Frame
week26 (week1 to week26)
Title
Serum intestinal permeability index-FABP2
Description
Change of Serum intestinal permeability index will be assessed during the the double-blind phase- FABP2
Time Frame
week26(week1 to week26)
Title
Serum intestinal permeability index-sCD14
Description
Change of Serum intestinal permeability index will be assessed during the the double-blind phase-sCD14
Time Frame
week26(week1 to week26)
Title
Serum intestinal permeability index-LBP
Description
Change of Serum intestinal permeability index will be assessed during the the double-blind phase-LBP
Time Frame
week26(week1 to week26)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YingYing Dong, M.D.
Phone
0086-13992808564
Email
406022725@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiancang Ma, M.D.
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiao tong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiancang Ma, M.D.
Phone
0086-13002951782
Email
maxiancang@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If necessary, part of the data can be obtained through the project leader.

Learn more about this trial

Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia

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