SchizophreniaNCT04291469
Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia
A study testing Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables), Prebiotics (Combined inulin and maltodextrin tables) and maltodextrin in people with Schizophrenia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
In this study, investigators will evaluate the efficacy and related mechanism of probiotics and prebiotics as an add-on treatment in improving the antipsychotic induced psychotic syndrome, the cognitive impairment, gastrointestinal function, and metabolic disorders in schizophrenia patients, through genotype… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables), Prebiotics (Combined inulin and maltodextrin tables) and maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2022to Dec 2022
- 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
- Duration of illness 5 years, Subjects are currently receiving first-line recommended antipsychotic medication
- The total PANSS score ≥60, containing at least three positive or negative items with scores of 3 or more at screening
- Junior high school or above
- Capacity for written informed consent.
Who cannot join
- Pregnant or lactating women
- Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, abnormal liver function, renal failure, immunodeficiency diseases, cancer, or gastrointestinal diseases ( inflammatory bowel disease or celiac disease, except functional constipation)
- Subjects had acute or chronic infections or are taking anti-inflammatory drugs and cortisol hormones. Receipt of antibiotic medication within the previous 1 month.
- Other neuropsychiatric disorders (organic diseases of the central nervous system, a mental disorder caused by a physical disease or psychoactive substance, mental retardation).
- Having history of substance dependence or abuse，including alcohol
- BMI is not within the normal range (18.5 to 23.9)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiao tong University
Xi’an, Shanxi, 710061
Xiancang Ma, M.D., 0086-13002951782, maxiancang@163.com
About this study
Official title: A Prospective, Randomized, Controlled Multicenter Trial of Probiotics and Prebiotics to Improve the Efficacy of Antipsychotics in Patients With Schizophrenia
In this study, investigators will evaluate the efficacy and related mechanism of probiotics and prebiotics as an add-on treatment in improving the antipsychotic induced psychotic syndrome, the cognitive impairment, gastrointestinal function, and metabolic disorders in schizophrenia patients, through genotype identification, psychopathology, neuropsychology, biochemical evaluation and other methods.
Read the detailed description
The study will recruit 210 schizophrenia patients who meet the criteria of DSM-4, and then randomized to 3 groups: control group, probiotics group and prebiotics group for a 14-weeks clinical trail and 12-weeks follow-up period. In addition to probiotics, prebiotic or maltodextrin interventions, in the meantime, all participants will also use one of the prescribed antipsychotics medications. Clinical efficacy and safety assessment will be done at baseline, clinical trail and follow-up period. The specific aims are to evaluate these tips: 1) psychotic syndrome; 2) cognition; 3) Gastrointestinal function; 4) inflammatory and metabolic related markers. Psychotic syndrome will be measured by the Positive and Negative Syndrome Scale. Cognitive function will be assessed by the MATRICS Consensus Cognitive Battery. Gastrointestinal function will be assessed by gastrointestinal symptom assessment scale (GSRS). Biological samples also will be collected, and stored to research Intestinal inflammation, intestinal permeability, intestinal flora and other indicators.
- Conditions
- Schizophrenia
- Being tested
- Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables), Prebiotics (Combined inulin and maltodextrin tables), maltodextrin
- Keywords
- Schizophrenia, Probiotics
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)Drug
Also called Probiotic bacteria
The probiotic compound will consist of tables containing approximately 10^9 colony forming units of the probiotic organisms, Lactobacillus and Bifidobacteria lactis strain，mixed maltodextrin(oral, daily for 14 weeks).
Prebiotics (Combined inulin and maltodextrin tables)Dietary supplement
The prebiotic compound will consist of tables containing inulin and maltodextrin (oral,daily for 14 weeks)
maltodextrinDietary supplement
Maltodextrin tables (oral,daily for 14 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Identical-appearing Placebo (maltodextrin tables) ,oral, daily for 14 weeks Receives: Dietary Supplement: maltodextrin |
| Probiotics group | Experimental | Combined Bifidobacteria+lactobacillus+maltodextrin tables, each table contain more than 1.0*10^9 colony forming units, oral, daily for 14 weeks Receives: Drug: Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables) |
| Prebiotics group | Experimental | Combined inulin+maltodextrin tables, oral, daily for 14 weeks Receives: Dietary Supplement: Prebiotics (Combined inulin and maltodextrin tables) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Syndrome Scale (PANSS) Score from week0 to week26
The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The clinical efficacy was evaluated by its score reduction rate, with the total score reduction rate ≥75% as recovery, 50% ~ 74% as significant improvement, 25% ~ 49% as improvement, and <25% as invalid. improvement, significant improvement and recovery add up to apparent effect.
Measured: 26weeks(week0 to week26)
Secondary outcomes (15)
Change in MATRICS Consensus Cognitive Battery(MCCB) Score from week1 to week26
Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) score from the start of Trial period to the end of the follow-up phase; Cognitive performance is measured by the MATRICS Consensus Cognitive Battery composite score in participants.
Measured: week26(week1 to week26 )
Gastrointestinal symptom rating scale (GSRS)
Gastrointestinal function will be assessed during the screening stage，week 4, week 8, week 12, week 14 of treatment stage and once every 4 weeks of follow-up stage through Gastrointestinal symptom rating scale (GSRS); The score reduction of GSRS≥25% was associated with improvement in gastrointestinal function.
Measured: week26 (week1 to week26)
Serum inflammatory factors-TH-1
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --TH-1
Measured: week26(week1 to week26)
Serum inflammatory factors-TH-2
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--TH-2
Measured: week26(week1 to week26)
Serum inflammatory factors-TH-17
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--TH-17
Measured: week26(week1 to week26)
Serum inflammatory factors-Interleukin-1
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines--Interleukin-1
Measured: week26(week1 to week26)
Serum inflammatory factors-Interleukin-2
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-2
Measured: week26(week1 to week26)
Serum inflammatory factors-Interleukin-6
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-6
Measured: week26(week1 to week26)
Serum inflammatory factors-Interleukin-10
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-10
Measured: week26(week1 to week26)
Serum inflammatory factors-Interleukin-17
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --Interleukin-17
Measured: week26(week1 to week26)
Serum inflammatory factors-TNF-a
Change of intestinal inflammation will be assessed during the the double-blind phase, including serum inflammatory cytokines --TNF-a(tumor necrosis factor-a,interferon).
Measured: week26(week1 to week26)
Fecal intestinal flora
The number of lactobacillus and bifidobacterium flora will be assessed; The species and abundance of intestinal flora were identified by 16SrRNA.
Measured: week26 (week1 to week26)
Serum intestinal permeability index-FABP2
Change of Serum intestinal permeability index will be assessed during the the double-blind phase- FABP2
Measured: week26(week1 to week26)
Serum intestinal permeability index-sCD14
Change of Serum intestinal permeability index will be assessed during the the double-blind phase-sCD14
Measured: week26(week1 to week26)
Serum intestinal permeability index-LBP
Change of Serum intestinal permeability index will be assessed during the the double-blind phase-LBP
Measured: week26(week1 to week26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start3 Mar 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- BaoJi Rehabilitation Hospital, Xiangyang Central Hospital, WeiNan Psychiatry Hospital, HanZhong Psychiatric Hospital
- Responsible party
- Sponsor
- Investigators
- Xiancang Ma, M.D., Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291469
- Sponsor's protocol ID
- XJTU1AF-CRF-2019-003
- Status last verified
- Apr 2022
- First submitted
- 13 Feb 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If necessary, part of the data can be obtained through the project leader.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Multicenter Trial of Probiotics and Prebiotics to Improve the Efficacy of Antipsychotics in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT04291469
- Acronym / sponsor ID
- XJTU1AF-CRF-2019-003
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- BaoJi Rehabilitation Hospital, Xiangyang Central Hospital, WeiNan Psychiatry Hospital, HanZhong Psychiatric Hospital
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Mar 2020 (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, investigators will evaluate the efficacy and related mechanism of probiotics and prebiotics as an add-on treatment in improving the antipsychotic induced psychotic syndrome, the cognitive impairment, gastrointestinal function, and metabolic disorders in schizophrenia patients, through genotype identification, psychopathology, neuropsychology, biochemical evaluation and other methods.
Detailed description
The study will recruit 210 schizophrenia patients who meet the criteria of DSM-4, and then randomized to 3 groups: control group, probiotics group and prebiotics group for a 14-weeks clinical trail and 12-weeks follow-up period. In addition to probiotics, prebiotic or maltodextrin interventions, in the meantime, all participants will also use one of the prescribed antipsychotics medications. Clinical efficacy and safety assessment will be done at baseline, clinical trail and follow-up period. The specific aims are to evaluate these tips: 1) psychotic syndrome; 2) cognition; 3) Gastrointestinal function; 4) inflammatory and metabolic related markers. Psychotic syndrome will be measured by the Positive and Negative Syndrome Scale. Cognitive function will be assessed by the MATRICS Consensus Cognitive Battery. Gastrointestinal function will be assessed by gastrointestinal symptom assessment scale (GSRS). Biological samples also will be collected, and stored to research Intestinal inflammation, intestinal permeability, intestinal flora and other indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: maltodextrinIdentical-appearing Placebo (maltodextrin tables) ,oral, daily for 14 weeks |
| Probiotics group | Experimental | Drug: Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)Combined Bifidobacteria+lactobacillus+maltodextrin tables, each table contain more than 1.0*10^9 colony forming units, oral, daily for 14 weeks |
| Prebiotics group | Experimental | Dietary Supplement: Prebiotics (Combined inulin and maltodextrin tables)Combined inulin+maltodextrin tables, oral, daily for 14 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia
- Duration of illness 5 years, Subjects are currently receiving first-line recommended antipsychotic medication
- The total PANSS score ≥60, containing at least three positive or negative items with scores of 3 or more at screening
- Junior high school or above
- Capacity for written informed consent.
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, abnormal liver function, renal failure, immunodeficiency diseases, cancer, or gastrointestinal diseases ( inflammatory bowel disease or celiac disease, except functional constipation)
- Subjects had acute or chronic infections or are taking anti-inflammatory drugs and cortisol hormones. Receipt of antibiotic medication within the previous 1 month.
- Other neuropsychiatric disorders (organic diseases of the central nervous system, a mental disorder caused by a physical disease or psychoactive substance, mental retardation).
- Having history of substance dependence or abuse，including alcohol
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 |
|---|---|---|
| Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)Also: Probiotic bacteriaThe probiotic compound will consist of tables containing approximately 10^9 colony forming units of the probiotic organisms, Lactobacillus and Bifidobacteria lactis strain，mixed maltodextrin(oral, daily for 14 weeks). | Drug | Probiotics group |
| Prebiotics (Combined inulin and maltodextrin tables)The prebiotic compound will consist of tables containing inulin and maltodextrin (oral,daily for 14 weeks) | Dietary supplement | Prebiotics group |
| maltodextrinMaltodextrin tables (oral,daily for 14 weeks) | Dietary supplement | Control group |
Primary outcome
Change in Positive and Negative Syndrome Scale (PANSS) Score from week0 to week26
Time frame: 26weeks(week0 to week26)
The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The clinical efficacy was evaluated by its score reduction rate, with the total score reduction rate ≥75% as recovery, 50% ~ 74% as significant improvement, 25% ~ 49% as improvement, and <25% as invalid. improvement, significant improvement and recovery add up to apparent effect.
15 secondary outcomes
Change in MATRICS Consensus Cognitive Battery(MCCB) Score from week1 to week26
Time frame: week26(week1 to week26 )
Gastrointestinal symptom rating scale (GSRS)
Time frame: week26 (week1 to week26)
Serum inflammatory factors-TH-1
Time frame: week26(week1 to week26)
Serum inflammatory factors-TH-2
Time frame: week26(week1 to week26)
Serum inflammatory factors-TH-17
Time frame: week26(week1 to week26)
Serum inflammatory factors-Interleukin-1
Time frame: week26(week1 to week26)
Serum inflammatory factors-Interleukin-2
Time frame: week26(week1 to week26)
Serum inflammatory factors-Interleukin-6
Time frame: week26(week1 to week26)
Serum inflammatory factors-Interleukin-10
Time frame: week26(week1 to week26)
Serum inflammatory factors-Interleukin-17
Time frame: week26(week1 to week26)
Serum inflammatory factors-TNF-a
Time frame: week26(week1 to week26)
Fecal intestinal flora
Time frame: week26 (week1 to week26)
Serum intestinal permeability index-FABP2
Time frame: week26(week1 to week26)
Serum intestinal permeability index-sCD14
Time frame: week26(week1 to week26)
Serum intestinal permeability index-LBP
Time frame: week26(week1 to week26)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No. If necessary, part of the data can be obtained through the project leader.
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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.
Xiancang Ma, M.D. study chair
First Affiliated Hospital Xi'an Jiaotong 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 Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables), Prebiotics (Combined inulin and maltodextrin tables) and maltodextrin in people with Schizophrenia, run by First Affiliated Hospital Xi'an Jiaotong 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YingYing Dong, M.D. (0086-13992808564, 406022725@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and Negative Syndrome Scale (PANSS) Score from week0 to week26 (time frame: 26weeks(week0 to week26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2022.