Overview

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

Status:
Recruiting
Trial end date:
2021-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Central South University
Criteria
Inclusion Criteria:

1. Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for
schizophrenia or bipolar disorder;

2. Patients with a weight gain of more than 10% after taking antipsychotic medications;

3. Male and female with aged 18 to 65 years;

4. PANSS total score < 60 or HAMD-17 total scoreā‰¤ 7 and YMRS total score<5;

5. Signed the study consent for participation;

6. Not allergy to probiotics or dietary fiber medicine

7. On stable medication and dosage for at least 3 months.

Exclusion Criteria:

1. Having history of substance dependence or abuse or whose symptoms are caused by the
other diagnosable mental disorders;

2. Having history of traumatic brain injury, seizures or other known neurological or
organic diseases of the central nervous system;

3. Taking antidepressants, stimulants, mood stabilizer or accepts electricity shock
treatment;

4. Having current suicidal or homicidal thoughts or any safety concern by research staff
that cannot be manage in an inpatient setting;

5. The routine blood tests showing abnormal renal, liver function;

6. Pregnant or lactating women.

7. No administration of any antibiotics in two mouths