NCT04291469

Antipsychotic Effects of Probiotics and Prebiotics on Patients With Schizophrenia

A Prospective, Randomized, Controlled Multicenter Trial of Probiotics and Prebiotics to Improve the Efficacy of Antipsychotics in Patients With Schizophrenia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)	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).
DIETARY_SUPPLEMENT	Prebiotics (Combined inulin and maltodextrin tables)	The prebiotic compound will consist of tables containing inulin and maltodextrin (oral,daily for 14 weeks)
DIETARY_SUPPLEMENT	maltodextrin	Maltodextrin tables (oral,daily for 14 weeks)

Timeline

• Start date: 2022-03-03
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-03-02
• Last updated: 2022-04-08

Locations

1 site across 1 country: China