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A 12-weeks Study to Evaluate the Dietary Fiber and Probiotics Treatment in Prevention and Intervention of Weight-gain and Cognitive Impairment of Schizophrenia or Bipolar Disorder

NCT03379597 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-04-19

No results posted yet for this study

Summary

In this study, the investigators will evaluate the efficacy, safety and related mechanism of dietary fiber and probiotics alone and in combination as a add-on treatment in improving the antipsychotic induced weight gain, the cognitive impairment, and psychotic syndrome in schizophrenia or bipolar disorder patients. The study will recruit 100 schizophrenia or bipolar disorder patients who meet the criteria of DSM-5, and then randomized to 4 groups: probiotics group(PB group) dietary fiber group(FB group) probiotics plus dietary fiber group(PF group) and control group(CT group) for a 12-weeks clinical trail. The specific aims are to compare probiotics group versus controls on: 1) clinical core symptoms; 2) cognition;3)metabolic related markers.

Conditions

Interventions

DRUG

Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)

Bifico 840mg Bid

DIETARY_SUPPLEMENT

Dietary fiber

dietary fiber compound powder 30g bid

Sponsors & Collaborators

  • Central South University

    lead OTHER

Principal Investigators

  • DongYu Kang, M.D. · Central South University

  • SuJuan Li, M.D. · Central South University

  • RenRong Wu, M.D. Ph.D. · Central South University

  • Chenchen Liu, M.D. · Central South 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
2017-11-30
Primary Completion
2021-05-31
Completion
2021-06-30

Countries

  • China

Study Locations

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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 NCT03379597 on ClinicalTrials.gov