Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia

NCT04291469 | Unknown

• 1 other identifier: XJTU1AF-CRF-2019-003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 identification, psychopathology, neuropsychology, biochemical evaluation and other methods.

Conditions

Schizophrenia

Keywords

Schizophrenia; Probiotics

Outcome Measures

Primary Outcomes (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.

  26weeks(week0 to week26)

Secondary Outcomes (15)

• Change in MATRICS Consensus Cognitive Battery(MCCB) Score from week1 to week26

  week26(week1 to week26 )

• Gastrointestinal symptom rating scale (GSRS)

  week26 (week1 to week26)

• Serum inflammatory factors-TH-1

  week26(week1 to week26)

• Serum inflammatory factors-TH-2

  week26(week1 to week26)

• Serum inflammatory factors-TH-17

  week26(week1 to week26)

Study Arms (3)

Control group

PLACEBO COMPARATOR

Identical-appearing Placebo (maltodextrin tables) ,oral, daily for 14 weeks

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

Drug: Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)

Prebiotics group

EXPERIMENTAL

Combined inulin+maltodextrin tables, oral, daily for 14 weeks

Dietary Supplement: Prebiotics (Combined inulin and maltodextrin tables)

Interventions

Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables) DRUG

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).

Also known as: Probiotic bacteria

Probiotics group

Prebiotics (Combined inulin and maltodextrin tables) DIETARY_SUPPLEMENT

The prebiotic compound will consist of tables containing inulin and maltodextrin (oral,daily for 14 weeks)

Prebiotics group

maltodextrin DIETARY_SUPPLEMENT

Maltodextrin tables (oral,daily for 14 weeks)

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• BaoJi Rehabilitation Hospital: collaborator
• Xiangyang Central Hospital: collaborator
• WeiNan Psychiatry Hospital: collaborator
• HanZhong Psychiatric Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiao tong University

Xi’an, Shanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Lacteol; Prebiotics; maltodextrin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Xiancang Ma, M.D.

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

YingYing Dong, M.D.

CONTACT

0086-13992808564; 406022725@qq.com

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: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: March 2, 2020
• Study Start: March 3, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)