Elnaz Vaghef-Mehrabani
1, Aziz Homayouni-Rad
2, Beitullah Alipour
3, Leila Vaghef-Mehrabany
4, Maryam Saghafi-Asl
5*1 Students Research Committee, Department of Biochemistry and Diet Therapy, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.
2 Department of Food Science and Technology, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.
3 Department of Nutrition in Community, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.
4 Department of Nutrition, School of Nutrition and Diet Therapy, Tehran University of Medical Sciences, Tehran, Iran.
5 Department of Biochemistry and Diet Therapy, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.
Abstract
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.