SchizophreniaNCT03379597
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
A study testing Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral) and Dietary fiber in people with Schizophrenia and Bipolar Disorder, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral) and Dietary fiber
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral), Dietary fiber
- Keywords
- Schizophrenia, probiotics, cognitive impairment, Metabolic syndrome, clinical trail, Efficacy, Safety, Dietary fiber, Bipolar Disorder
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Cognitive Dysfunction, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)Drug
Bifico 840mg Bid
Dietary fiberDietary supplement
dietary fiber compound powder 30g bid
| Study group | Role | What they receive |
|---|---|---|
| Probiotics Group | Experimental | Probiotics add-on treatment :（live Combined Bifidobacterium, Lactobacillus and Enterococcus Capsules, Oral）, each capsule contain more then 1.0*10^7 CFU.
Bifico: 840mg Bid. Receives: Drug: Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral) |
| Control Group | No intervention | No probiotics or dietary fiber group. |
| Dietary fiber Group | Experimental | Prebiotics add-on treatment: dietary fibers compound powder, 30g bid Receives: Dietary Supplement: Dietary fiber |
| Dietary fiber Probiotics group | Experimental | Dietary fiber and probiotics group: receiving both Bifico 840mg Bid and dietary fiber 30g bid. Receives: Drug: Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral); Dietary Supplement: Dietary fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
Positive And Negative Syndrome Scale (PANSS)
The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point.
Measured: 12 weeks
Lipid metabolism related blood index
Other lipid metabolism related marker such as LDL,HDL,TG, CHO (all in mmol/L)
Measured: 12 weeks
Physical exam index
Body weight related physical exam index: waist circumference,hip line (cm)
Measured: 12 weeks
Hamilton Depression Scale and Young Manic Rating Scale (YMRS)
The change of total score of the Hamilton Depression Scale and the Young Manic Rating Scale (YMRS), used to measure mania and depression symptoms of bipolar disorder.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start30 Nov 2017
- Primary completion31 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
- Investigators
- DongYu Kang, M.D., Principal investigator, Central South UniversitySuJuan Li, M.D., Principal investigator, Central South UniversityRenRong Wu, M.D. Ph.D., Principal investigator, Central South UniversityChenchen Liu, M.D., Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379597
- Sponsor's protocol ID
- WU201711BIO
- Status last verified
- Feb 2022
- First submitted
- 29 Nov 2017
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xiao J, Liu C, Shao T, Kang D, Tang H, Liu F, Shi Z, Chen Y, Wu R, Zhao J, Huang J, Shao P. Circulating propionate and butyrate are associated with metabolic improvements following probiotic and dietary fiber supplementation in patients on antipsychotics: a post-hoc analysis of a randomized controlled trial. BMC Psychiatry. 2026 Jun 12. doi: 10.1186/s12888-026-08272-x. Online ahead of print.
PubMed 42286534Liu 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.
PubMed 33622382
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03379597
- Acronym / sponsor ID
- WU201711BIO
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- Schizophrenia, probiotics, cognitive impairment, Metabolic syndrome, clinical trail, Efficacy, Safety, Dietary fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Probiotics Group | Experimental | Drug: Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)Probiotics 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 intervention | –No probiotics or dietary fiber group. |
| Dietary fiber Group | Experimental | Dietary Supplement: Dietary fiberPrebiotics add-on treatment: dietary fibers compound powder, 30g bid |
| Dietary fiber Probiotics group | Experimental | Drug: Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral), Dietary Supplement: Dietary fiberDietary fiber and probiotics group: receiving both Bifico 840mg Bid and dietary fiber 30g bid. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)Bifico 840mg Bid | Drug | Dietary fiber Probiotics group, Probiotics Group |
| Dietary fiberdietary fiber compound powder 30g bid | Dietary supplement | Dietary fiber Group, Dietary fiber Probiotics group |
Primary outcome
MATRICS Consensus Cognitive Battery (MCCB) composite score
Time frame: 12 weeks
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.
Body Mass Index
Time frame: 12 weeks
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.
4 secondary outcomes
Positive And Negative Syndrome Scale (PANSS)
Time frame: 12 weeks
Lipid metabolism related blood index
Time frame: 12 weeks
Physical exam index
Time frame: 12 weeks
Hamilton Depression Scale and Young Manic Rating Scale (YMRS)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 42286534Xiao J, Liu C, Shao T, Kang D, Tang H, Liu F, Shi Z, Chen Y, Wu R, Zhao J, Huang J, Shao P. Circulating propionate and butyrate are associated with metabolic improvements following probiotic and dietary fiber supplementation in patients on antipsychotics: a post-hoc analysis of a randomized controlled trial. BMC Psychiatry. 2026 Jun 12. doi: 10.1186/s12888-026-08272-x. Online ahead of print.
- Derived from this study: PubMed 33622382Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DongYu Kang, M.D. principal investigator
Central South University
SuJuan Li, M.D. principal investigator
Central South University
RenRong Wu, M.D. Ph.D. principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral) and Dietary fiber in people with Schizophrenia and Bipolar Disorder, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MATRICS Consensus Cognitive Battery (MCCB) composite score (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03379597, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.