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
1 other identifier
interventional
136
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Nov 2017
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2017
CompletedStudy Start
First participant enrolled
November 30, 2017
CompletedFirst Posted
Study publicly available on registry
December 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedApril 19, 2023
February 1, 2022
3.5 years
November 29, 2017
April 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
MATRICS Consensus Cognitive Battery (MCCB) composite score
The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure before and after treatment at different follow up point.
12 weeks
Body Mass Index
The body mass index (BMI) or Quetelet index is a value derived from the mass (weight) and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
12 weeks
Secondary Outcomes (4)
Positive And Negative Syndrome Scale (PANSS)
12 weeks
Lipid metabolism related blood index
12 weeks
Physical exam index
12 weeks
Hamilton Depression Scale and Young Manic Rating Scale (YMRS)
12 weeks
Study Arms (4)
Probiotics Group
EXPERIMENTALProbiotics add-on treatment :（live Combined Bifidobacterium, Lactobacillus and Enterococcus Capsules, Oral）, each capsule contain more then 1.0\*10\^7 CFU. Bifico: 840mg Bid.
Control Group
NO INTERVENTIONNo probiotics or dietary fiber group.
Dietary fiber Group
EXPERIMENTALPrebiotics add-on treatment: dietary fibers compound powder, 30g bid
Dietary fiber Probiotics group
EXPERIMENTALDietary fiber and probiotics group: receiving both Bifico 840mg Bid and dietary fiber 30g bid.
Interventions
Bifico 840mg Bid
dietary fiber compound powder 30g bid
Eligibility Criteria
You may qualify if:
- Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia or bipolar disorder;
- Patients with a weight gain of more than 10% after taking antipsychotic medications;
- Male and female with aged 18 to 65 years;
- PANSS total score \< 60 or HAMD-17 total score≤ 7 and YMRS total score\<5;
- Signed the study consent for participation;
- Not allergy to probiotics or dietary fiber medicine
- On stable medication and dosage for at least 3 months.
You may not qualify if:
- Having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;
- Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
- Taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;
- Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
- The routine blood tests showing abnormal renal, liver function;
- Pregnant or lactating women.
- No administration of any antibiotics in two mouths
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Related Publications (1)
Liu C, Kang D, Xiao J, Huang Y, Peng X, Wang W, Xie P, Yang Y, Zhao J, Wu R. Dietary fiber and probiotics for the treatment of atypical antipsychotic-induced metabolic side effects: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2021 Feb 23;22(1):159. doi: 10.1186/s13063-021-05123-w.
PMID: 33622382DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
DongYu Kang, M.D.
Central South University
- PRINCIPAL INVESTIGATOR
SuJuan Li, M.D.
Central South University
- PRINCIPAL INVESTIGATOR
RenRong Wu, M.D. Ph.D.
Central South University
- PRINCIPAL INVESTIGATOR
Chenchen Liu, M.D.
Central South University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Central South University
Study Record Dates
First Submitted
November 29, 2017
First Posted
December 20, 2017
Study Start
November 30, 2017
Primary Completion
May 31, 2021
Study Completion
June 30, 2021
Last Updated
April 19, 2023
Record last verified: 2022-02