Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-03

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

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

Group Type PLACEBO_COMPARATOR

maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin tables (oral,daily for 14 weeks)

Probiotics group

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

Group Type EXPERIMENTAL

Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)

Intervention Type 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).

Prebiotics group

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

Group Type EXPERIMENTAL

Prebiotics (Combined inulin and maltodextrin tables)

Intervention Type DIETARY_SUPPLEMENT

The prebiotic compound will consist of tables containing inulin and maltodextrin (oral,daily for 14 weeks)

Interventions

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Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)

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 DRUG

Prebiotics (Combined inulin and maltodextrin tables)

The prebiotic compound will consist of tables containing inulin and maltodextrin (oral,daily for 14 weeks)

Intervention Type DIETARY_SUPPLEMENT

maltodextrin

Maltodextrin tables (oral,daily for 14 weeks)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Probiotic bacteria

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No