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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

YingYing Dong, M.D. contact

0086-13992808564

406022725@qq.com

China1 site, 1 recruiting

  • First Affiliated Hospital of Xi'an Jiao tong University

    Xi’an, Shanxi, 710061

    Xiancang Ma, M.D., 0086-13002951782, maxiancang@163.com

    Recruiting

Other trials in China

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 groups in NCT04291469
Study groupRoleWhat they receive
Control groupPlacebo comparatorIdentical-appearing Placebo (maltodextrin tables) ,oral, daily for 14 weeks
Receives: Dietary Supplement: maltodextrin
Probiotics groupExperimentalCombined 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 groupExperimentalCombined 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.

  1. 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)

  1. 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 )

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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.

  1. First posted2 Mar 2020
  2. Study start3 Mar 2022
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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)
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.

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?

On the ClinicalTrials.gov record for NCT04291469.

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.

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