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

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. 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.

Timeline

Start

2017-11-30

Primary completion

2021-05-31

Completion

2021-06-30

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.
• Liu 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.

Drugs

Indications