Effects of Lactobacillus casei supplementation on disease activity and inflammatory cytokines in rheumatoid arthritis patients: a randomized double-blind clinical trial

Int J Rheum Dis. 2014 Jun;17(5):519-27. doi: 10.1111/1756-185X.12333. Epub 2014 Mar 27.


Aim: The present study aimed at investigating the effects of Lactobacillus casei 01 supplementation on symptoms and inflammatory biomarkers of rheumatoid arthritis (RA) in women.

Method: In this randomized double-blind clinical trial, female patients with established RA for more than 1 year, 20-80 years of age and body mass index (BMI) lower than 40, who followed stable medication for 3 months prior to the supplementation, were randomly allocated to receive either one capsule containing 10(8) colony forming units (CFU) of L. casei 01, or a placebo for 8 weeks; allocation was stratified by BMI and menopausal status. Disease activity score-28 (DAS28) was calculated, European League Against Rheumatism (EULAR) response was evaluated and the cytokines, interleukin (IL)-1β, IL-6, IL-10, IL-12 and tumor necrosis factor (TNF)-α were measured.

Results: Thirty patients were recruited in each group; 22 and 24 patients were analyzed in the probiotic and placebo groups, respectively. L. casei 01 supplementation decreased serum high-sensitivity C-reactive protein (hs-CRP) levels, tender and swollen joint counts, global health (GH) score and DAS28 (P < 0.05). More patients in the L. casei 01 group had moderate response to the treatment, based on the EULAR criteria, at the end of the study (P < 0.01). At the end of the study, a significant difference was observed between the two groups for IL-10, IL-12 and TNF-α changes through the study course (P < 0.05), in favor of the probiotic group. No adverse effects were reported for the intervention.

Conclusion: Probiotic supplementation may be an appropriate adjunct therapy for RA patients and help alleviate symptoms and improve inflammatory cytokines.

Keywords: DAS28; EULAR criteria; inflammatory cytokines; probiotics; rheumatoid arthritis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Arthritis, Rheumatoid / blood
  • Arthritis, Rheumatoid / diagnosis
  • Arthritis, Rheumatoid / immunology
  • Arthritis, Rheumatoid / microbiology
  • Arthritis, Rheumatoid / therapy*
  • Biomarkers / blood
  • Cytokines / blood*
  • Disability Evaluation
  • Double-Blind Method
  • Female
  • Humans
  • Inflammation Mediators / blood*
  • Intestines / microbiology*
  • Iran
  • Joints / pathology
  • Lacticaseibacillus casei / physiology*
  • Middle Aged
  • Probiotics / therapeutic use*
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Biomarkers
  • Cytokines
  • Inflammation Mediators

Associated data

  • IRCT/20120623405N9