Abstract
BackgroundLactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications.MethodsForty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).ResultsSubjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052) and statistically significant improvement in Pain Scale (P = .046) vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study.ConclusionsResults of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results.Trial registrationACTRN12609000435280
Highlights
Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and antiinflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans
The objective was to evaluate the effects of Bacillus coagulans GBI-30, 6086 on rheumatoid arthritis (RA) symptoms compared with placebo
Forty-five men and women who had RA for at least 1 year were enrolled in the study and randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day for 60 days (Figure 1)
Summary
Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and antiinflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications. Despite the number of effective pharmacological agents available today, a substantial proportion of patients will experience persistent, low-level disease activity [10]. This underscores the need for adjunctive therapies that are safe and can help relieve the painful symptoms of arthritis
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