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Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia

NCT04291469 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-04-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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).

DIETARY_SUPPLEMENT

Prebiotics (Combined inulin and maltodextrin tables)

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

DIETARY_SUPPLEMENT

maltodextrin

Maltodextrin tables (oral,daily for 14 weeks)

Sponsors & Collaborators

  • BaoJi Rehabilitation Hospital

    collaborator UNKNOWN

  • Xiangyang Central Hospital

    collaborator OTHER

  • WeiNan Psychiatry Hospital

    collaborator UNKNOWN

  • HanZhong Psychiatric Hospital

    collaborator UNKNOWN

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Xiancang Ma, M.D. · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291469 on ClinicalTrials.gov