Formulation and Design of Probiotic Supplements for Rheumatoid Arthritis Patients

Background: Probiotics are live microorganisms with immune-regulatory properties and may be useful for patients suffering from rheumatoid arthritis (RA), an autoimmune inflammatory disorder. The aim of the present study was to formulate L. casei 01 capsules at laboratory scale, and evaluate its effects on the proportion of T-helper type 2 (Th2) anti-inflammatory cytokines to T-helper type 1 (Th1) pro-inflammatory cytokines (Th2/Th1), in RA patients. Methods: After blending the probiotic and excipient (maltodextrin) based on the relevant calculations, the content uniformity of the mixture was evaluated. Furthermore, viability of the probiotic bacteria was assessed during capsules production and throughout three months of storage. In a randomized double-blind placebo-controlled trial, 46 RA patients were supplemented with either the capsules (containing at least 108 CFU of Lactobacillus. casei 01) or placebo (maltodextrin), for eight weeks; DAS28 (Disease activity score 28) as well as serum inflammatory cytokines (TNF-α, IL-1β, IL-6, IL-10 and IL-12) were measured at baseline and the end of study. IL-10/IL-1β, IL-10/IL-6, IL-10/IL-12, IL10/TNF-α and IL-10/(IL-1β+ IL-6+ IL-12+ TNF-α) were calculated, the latter being expressed as IL-10/total Th1, and compared for the groups. Paired samples t test, Wilcoxon signed-rank test and ANCOVA tests were applied. Results: Probiotic powder had been uniformly mixed with the excipient and the bacteria had acceptable viability throughout the study course. Supplementation of RA patients with the capsules resulted in a significant decrease in disease activity (DAS28, P=0.039) and increase in IL-10/TNF-α, IL-10/IL-12 and IL-10/total Th1 (P=0.039, P=0.012 and P=0.014, respectively). At the end of the study, there was a significant difference between the two groups in terms of IL-10/IL-12 and IL-10/total Th1 (P= 0.038 and P= 0.006, respectively). Conclusion: L. casei 01 supplements may have the expected desired anti-inflammatory effects in RA patients. Further clinical trials are warranted to confirm these results.