Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia

Xi'an Jiaotong University

Status: Unknown

Conditions: Schizophrenia

Treatments: Dietary Supplement: maltodextrin; Dietary Supplement: Prebiotics (Combined inulin and maltodextrin tables); Drug: Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)

Study type: Interventional

Funder types: Other

Identifiers

NCT04291469

XJTU1AF-CRF-2019-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: maltodextrin

Probiotics group

Experimental group

Description:

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

Treatment:

Drug: Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)

Prebiotics group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Prebiotics (Combined inulin and maltodextrin tables)