Clinical trial NCT03379597: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Keywords: Schizophrenia
probiotics
cognitive impairment
Metabolic syndrome
clinical trail
Efficacy
Safety
Dietary fiber
Bipolar Disorder
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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 (20 patients per arm) for a 12-weeks clinical trail. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare probiotics group versus controls on: 1) clinical core symptoms; 2) cognition; 3) metabolic related markers. Biological samples also will be collected, and stored to research related mechanisms. Clinical symptoms will be measured by the Positive and Negative Syndrome Scale,. Cognitive function will be assessed by the MATRICS Consensus Cognitive Battery.

The investigators hypothesize that: 1) dietary fiber and probiotics may improve cognitive impairment of patients with schizophrenia; 2) dietary fiber and probiotics could prevent the cognitive decline of patients with schizophrenia; 3)dietary fiber and probiotics may prevent the antipsychotics induced weight gain in patients with schizophrenia.4)dietary fiber and probiotics may alter oxidative stress indexes or inflammatory biomarkers thus influence the oxidative and inflammatory mechanism.

Eligibility 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 score≤ 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

Primary outcomes:
measure: MATRICS Consensus Cognitive Battery (MCCB) composite score
timeFrame: 12 weeks
measure: Body Mass Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Positive And Negative Syndrome Scale (PANSS)
timeFrame: 12 weeks
measure: Lipid metabolism related blood index
timeFrame: 12 weeks
measure: Physical exam index
timeFrame: 12 weeks
measure: Hamilton Depression Scale and Young Manic Rating Scale (YMRS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: DongYu Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central South University
name: SuJuan Li, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central South University
name: RenRong Wu, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central South University
name: Chenchen Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.