The Effect of Adjunctive Probiotics on Markers of Inflammation and Oxidative Stress in Bipolar Disorder: A Double-blind, Randomized, Controlled Trial.

BACKGROUND: Bipolar disorder (BD) is a chronic psychiatric illness. Concentrations of inflammatory cytokines are increased in BD. Supplementation with probiotics has shown promising effects in reducing inflammation and producing improvement in clinical symptoms in some psychiatric disorders. Therefore, we designed a clinical trial to assess the effects of adjunctive probiotics on markers of inflammation and oxidative stress in patients with BD. METHODS: In this 8-week, double-blind, randomized study, 38 patients suffering from BD type I were given a probiotic or placebo capsule each day. Serum levels of interleukin-6 (IL-6), as the primary outcome measure, and of interleukin-10 (IL-10), tumor necrosis factor-α, and malondialdehyde, as the secondary outcome measures, were obtained before and after the intervention. RESULTS: At the end of the study, the 2 groups showed no significant or clinically meaningful differences in the serum concentrations of IL-6 [Hedge g=0.02, 95% confidence interval (CI): -0.6; 0.64, P=0.936], tumor necrosis factor-α (Hedge g=-0.2, 95% CI: -0.82; 0.42, P=0.554), IL-10 (Hedge g=-0.072, 95% CI: -0.071; 0.56, P=0.827), and malondialdehyde (Hedge g=0.27, 95% CI: -0.37; 0.91, P=0.423). CONCLUSIONS: This study did not find any significant or conclusive effects of probiotics supplementation on markers of inflammation and oxidative stress in patients with BD. Further studies are needed before a conclusion can be drawn about the efficacy of probiotics in the management of BD.

The Efficacy of Probiotics for Treatment of Bipolar Disorder-Type 1: A Randomized, Double-Blind, Placebo Controlled Trial.

Objective: Bipolar disorders are among the most common chronic mental disorders. Despite the recent improvement in controlling psychiatric disorders, treatment of bipolar disorders remains a challenge. The aim of this study was to determine the effect of consuming probiotics in patients with bipolar disorder-type 1 compared to the placebo group. Method : This was a permuted blocked randomized clinical trial conducted in Shahid Beheshti mental hospital in Kerman, Iran, from October 2017 to October 2018. Two psychiatrists diagnosed and hospitalized all 38 patients with type 1 bipolar disorder based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Using blind randomized blocking method size 4, patients were divided into 2 groups of placebo and probiotic. Young Mania Rating Scale (YMRS) and Hamilton's Depression Rating Scale (HDRS) were completed at the beginning, week 4, and week 8 of the study by a psychiatry resident. Independent t test, Mann-Whitney and repeated measures ANOVA tests were used. Data were analyzed using SPSS software version 20. Results: There was no significant difference between the 2 groups in age, sex, and severity of mania and depression. Consumption of probiotics reduced the scores of YMRS and HDRS over time in the probiotic group more than the placebo group, but it was not significant. Conclusion: Consumption of probiotics had non-significant effects on improvement and treatment of bipolar type 1 patients. It is suggested that future studies be conducted with different probiotic microbial strains and longer period of treatment.